Biostatisticians

Description

About the Company:

ANS provides industry-leading nutritional solutions to promote health and wellbeing, enabled by a world class team dedicated to service, excellence, quality, and innovation. As an organization we take pride in achieving our objective of “More than Supplements... Solutions”...Safely. We want to be a “solution” through an engaged, accountable and CARING culture.

If you are looking for an exciting career opportunity with a company that offers exceptional benefits packages, then you have come to the right place!

· Most Competitive Pay in the Industry

· 401K Program

· Paid holidays

· Paid Time Off

· Medical/Dental benefits

· Employee and Family Events

· Annual Awards Program

· Best Employee Referral Program

The Opportunity…

· Strong track record of internal promotions

· Comprehensive Training program to encourage promotions

· Detailed Progression model to outline promotional opportunities

· Cross-functional opportunities to multiple different areas in the company

Supports R&D Managers with day to day tasks as needed.

· Follow all company policies and procedures.

· Follow and ensure compliance to quality system and cGMP programs.

· Research of raw materials, allergens, country of origin, sub-ingredient list, vegetarian status, etc.

· Ensure that required Technical Specifications are completed and submitted to the appropriate Salesperson or customer.

· Complete, populate and maintain the Raw Material Specifications, document repository, etc.

· Complete, populate and maintain the Finished Good Specification Sheets (FGSS), document repository, etc.

· Reference and utilize internal and external databases and references to answer customer inquiries.

· Populate and maintain databases as assigned.

· Assists other groups within R&D as directed.

Qualifications:

· Non-supervisory role.

· Must have applicable Associate’s degree or minimum 2 years of relevant experience.

· No certifications or licenses required.

· Must have moderate math skills.

· Moderate reading skills required.

· Must have basic computer skills in MS Office.

· Must have moderate language skills.

· Must have moderate writing skills.

· Must be willing to learn new tasks and procedures.

· Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to others or self.

· Maintains a regular and dependable work attendance record with few instances of unplanned and/or unexpected absence

Additional Information
Type of Employee
Direct Hire
Department
R&D
Shift
1st

Clinical Coordinator, Intermediate (North Valley/Phoenix, Arizona)

Location: Nursing

Regular/Temporary: Regular

Job ID: 608313

Full/Part Time: Full-Time

Workplace Culture

NAU aims to be the nation's preeminent engine of opportunity, vehicle of economic mobility, and driver of social impact by delivering equitable postsecondary value in Arizona and beyond.

https://nau.edu/president/strategic-plan/

Special Information

• Position located in Phoenix, Arizona at the North Valley NAU Campus.

Job Description

Are you passionate about ensuring nursing students receive high-quality clinical education? We are looking for a Clinical Coordinator to join our team at the College of Nursing in the NAU North Phoenix Campus! In this role, you will assist in coordinating student clinical placements and building strong relationships with faculty, students, and healthcare partners. Your work will ensure students gain meaningful, well-organized clinical experiences that align with their educational goals. Assisting with the coordination of all aspects of student clinical placements and operations to ensure the best clinical experiences for each individual student.You will work directly with the Assistant Director of Clinical Site Engagement and collaborate with the Director of the College of Nursing and North Valley faculty, students and clinical partners.

Who would make a great candidate? Someone with strong communication and relationship building skills, organizational skills, the ability to problem solve complex placement logistics, knowledge of healthcare settings along with clinical education requirements and also someone who has a passion for student success and professional development!

Clinical Coordination Liaison - 80%

• Serves as liaison for faculty, students and healthcare organizations.

• Promotes positive working relationships with clinical placement agencies, students, other health professions educational programs, and other institutions.

• Coordinates with faculty regarding course and clinical placement needs and requirements
• Networks with nursing employers and clinical partners in the community.

• Collaborates with various clinical units and sites to arrange student clinical experiences that meet course objectives.Represents the College of Nursing at clinical agency planning meetings to negotiate clinical sites, as well as community professional meetings and recruitment job fairs.

• Evaluates and monitors clinical units and sites used for clinical experiences.
• Provides support for clinical instructors as needed around clinical rotation requirements, processes, and deadlines.

• Orients, evaluates, and mentors clinical staff to ensure ongoing understanding of the student clinical placement process.

• Identifies facility requirements at each clinical site, such as onboarding and orientation requirements, communicates these clinical entry requirements to instructors and student groups in a timely manner, and ensures student onboarding is complete prior to rotation start date.
• Facilitates the resolution of any issues between the student and clinic/site.
• Establishes schedules of clinical assignments/rotations for each term for students and clinical faculty.
• Communicates confirmed or changed clinical rotations with clinical instructors and/or program coordinators, students, clinical site coordinators, and preceptors as appropriate in a timely manner.
• Collaborates with program faculty regarding ongoing and timely evaluation of student progress and/or difficulties; addresses any concerns regarding student's educational preparedness as well as any concerning behaviors.
• Ensures clinical faculty, preceptors, and students have timely access to any required forms and evaluations.

Administrative Support - 15%

• Initiates and maintains contracts required between the educational institution and the clinical agency.
• Maintains records of facility requirements, updating as necessary.
• Maintains database of preceptors, practice site information, and site evaluation forms.
• Maintains database of student demographic, clinical learning activities, and associated documentation.
• Maintains university and clinical agencies confidentiality requirements (e.g., HIPAA & FERPA).
• Maintains open lines of communication with students, faculty, staff, coordinators, directors, and the community at large which may include regular monitoring of email accounts (e.g., mailto:NVPlacements@nau.edu, mailto:gradnursing.clinical@nau.edu).
• Assisting with relevant event planning (e.g., student orientation).

Other - 5%

• Other duties as assigned.
• Act as a back-up clinical placement coordinator to other nursing programs/tracks as needed.

Minimum Qualifications

• Bachelor's degree.
• 2 to 4 years of relevant experience.
• A combination of related education, experience, and training may be used as an equivalent to the above educational minimum requirements.

Preferred Qualifications

• Registered nurse (RN).
• Previous experience with clinical placement coordination.
• Experience in sales.

Knowledge, Skills, & Abilities

• Knowledge of Health, Safety, and Emergency Preparedness policies and procedures.
• Knowledge of theories and methods of health education.
• Knowledge of project management.
• Knowledge of patient rights, patient consent, confidentiality and Health Insurance Portability and Accountability Act (HIPAA).
• Knowledge of healthcare vocabulary.
• Knowledge of the diverse organizational environments in different healthcare settings.
• Skills in prioritizing and completing multiple tasks of varying complexity and urgency in a timely and efficient manner.
• Customer service skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Establishes and maintains effective working relationships.
• Communicates effectively to both small and large groups.
• Possesses strong problem solving, organizational, and analytical capabilities.

Background Information

This position has been identified as a safety/security sensitive position. Therefore, per AZ Revised Statute, Northern Arizona University requires satisfactory results for the following: a criminal background investigation, employment history investigation, degree verification (in some cases) and fingerprinting. If you are applying for a job that requires a CDL, you will be required to register with the Federal Motor Carrier Safety Administration Drug & Alcohol Clearinghouse and adhere to the clearinghouse requirements. Additionally, as an employer in the state of Arizona, NAU is required to participate in the federal E-Verify program that assists employers with verifying new employees' right to work in the United States. Finally, each year Northern Arizona University releases an https://in.nau.edu/police-department/annual-security-and-fire-safety-reports/.. The report is a result of a federal law known as the Clery Act. The report includes Clery reportable crime statistics for the three most recent completed calendar years and discloses procedures, practices and programs NAU uses to keep students and employees safe including how to report crimes or other emergencies occurring on campus. In addition, the https://in.nau.edu/police-department/annual-security-and-fire-safety-reports/. is combined with the Annual Security Report for the NAU Flagstaff Mountain Campus as this campus has on-campus student housing. This report discloses fire safety policies and procedures related to on-campus student housing and statistics for fires that occurred in those facilities. If you would like a free paper copy of the report, please contact the NAUPD Records Department at (928) 523-8884 or by visiting the department at 525 E. Pine Knoll Drive in Flagstaff.

Salary

Salary range begins at $51,085. Annual salary commensurate with candidate's qualifications and related experience.

FLSA Status

This position is exempt from the overtime provisions of the Fair Labor Standards Act (FLSA) and therefore will not earn overtime or compensatory time for additional time worked.

Benefits

This is a Classified Staff (CLS) position. NAU offers an excellent benefit package including generous health, dental and vision insurance; participation in the Arizona State Retirement System; paid vacation and 10 holidays per year; and tuition reduction for employees and qualified dependents. More information on benefits at NAU is available on the https://in.nau.edu/Human-Resources/Benefits/. Classified Staff employees are in a probationary status for their first six months at NAU. NAU is a tobacco and smoke-free campus. Employees offered a position will be eligible for state health plans (including NAU's BCBS Plan). New employees arehttps://in.nau.edu/human-resources/benefits/ on the first day of the pay period following their enrollment, after their employment date. Employees will have 31 days from their start date to enroll in benefits. Additionally, new employees will begin participating in the Arizona State Retirement System, and the long-term disability coverage that accompanies it, on the first of the pay period following 6 months after the new employee's start date.

Learning and Development

Your career at Northern Arizona University includes the opportunity for professional development. https://in.nau.edu/human-resources/orientation/ includes courses to be completed within the first 30 days.

Immigration Suppt/Sponsorship

NAU will not provide any U.S. immigration support or sponsorship for this position.

Application Deadline

April 14, 2025 at 11:59 p.m.

How to Apply

To apply for this position, please click on the "Apply" button on this page. You must submit your application by clicking on the "Submit" button by midnight of the application deadline. If you need assistance completing your application there are instructions available on the https://in.nau.edu/human-resources/or in person in the Human Resources Department located in Building 91 on the NAU Campus - on the corner of Beaver and DuPont Streets.

If you are an individual with a disability and need reasonable accommodation to participate in the hiring process, please contact the Disability Resources Office at 928-523-8773, http://DR@nau.edu, or PO Box 5633, Flagstaff AZ 86011.

Equal Employment Opportunity

Northern Arizona University is a committed Equal Opportunity/Affirmative Action Institution. Women, minorities, veterans and individuals with disabilities are encouraged to apply. NAU is responsive to the needs of dual career couples.

https://in.nau.edu/Human-Resources/Posters-Required-by-Law/

NAU is an Employer of National Service. AmeriCorps, Peace Corps, and other National Service alumni are encouraged to apply.

To apply, visit https://apptrkr.com/6109098

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jeid-e4390911a0c888429b2c93f54e9aee64

**Summary:**

Meta is seeking a proactive and experienced Energy Research Analyst to support our energy industry research efforts within our Global Energy organization. The successful candidate will support a cross-functional effort, providing real-time, actionable insights on broader industry-related energy initiatives.

**Required Skills:**

Energy Research Analyst Responsibilities:

1. Track clean energy deals and investments, energy efficiency initiatives, and the use of new energy technologies to support data center strategies.

2. Monitor potential power sources for new data center campuses, both grid-connected and behind-the-meter.

3. Prepare industry research reports and create and maintain real-time dashboards and databases tracking new clean energy and energy efficiency projects.

4. Produce regular reports summarizing market strategies and investments and identifying potential opportunity areas.

5. Develop executive briefings on emerging trends in data center energy infrastructure and clean energy deployments.

6. Build and maintain relationships with internal partners including across Energy, Sustainability, Infrastructure Data Center Strategy, and policy organizations.

**Minimum Qualifications:**

Minimum Qualifications:

7. Bachelor's degree in a relevant field (e.g., economics, business, engineering, etc.)

8. 5+ years of experience in research, analysis, or related field

9. Demonstrated analytical and problem-solving skills

10. Proven communication, organizational and program management skills, with experience managing multiple projects and coordinating across internal and external stakeholders

11. Experience managing time-sensitive projects to completion while balancing evolving priorities

12. Experience building and maintaining cross-functional relationships enabling clear information flow across wide-ranging teams

13. Experience working as part of a team as well as under your own initiative, seeking feedback and input where appropriate

14. Experience and knowledge of energy market fundamentals and dynamics

15. Intermediate MS Office (Excel and PowerPoint) and G-Suite (Google Docs, Google Slides, Google Sheets)

**Preferred Qualifications:**

Preferred Qualifications:

16. Experience with data visualization tools (e.g., Tableau, Power BI)

**Public Compensation:**

$126,000/year to $179,000/year + bonus + equity + benefits

**Industry:** Internet

**Equal Opportunity:**

Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.

Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at accommodations-ext@fb.com.

Job Title : Research Associate I

Location : Oro Valley, AZ

Type: Contract, Potential for extension or conversion to permanent

Overview

Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support company projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities

+ Executes laboratory experiments; makes detailed observations and analyzes data.

+ Prepares technical reports, summaries and quantitative analyses.

+ Maintains complete and accurate records.

+ Normally receives detailed directions on all work.

+ Makes suggestions to improve work processes.

+ Assists in reducing to practice patentable inventions.

+ Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.

+ Exercises judgment within defined procedures and practices to determine appropriate action.

+ May participate in cross functional technical team activities.

+ Presents and discusses data within group.

+ Monitors work to ensure quality and continuously promote Quality First Time.

+ Other duties as assigned by management

Requirements

Education

+ Bachelor's Degree in Science

Experience

+ Entry Level – Less than 1 year required

Knowledge, Skills and Abilities

+ Knows basic and some specialized laboratory techniques.

+ Familiar with searching scientific literature.

+ Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

**Job Description:**

Job Summary:

The role of the Family Health Advocate-Research Analyst is an exciting and integral role in providing meaningful advocacy support to members and their families through personalized resource and referral facilitation, issue resolution and healthcare navigation. In this role you will provide research to support and resolve cases originating from our Family Health Advocates that require additional follow up. Case follow-ups include but are not limited to the coordination of benefits, health claim appeals, re-submissions and/or re-coding, EOB reviews and researching provider availability and scheduling appointments.

Essential Job Functions:

+ **Support follow up needs from Family Health Advocate calls** **for the following:**

+ Research and resolution to eligibility, claims issues, ID card issues, grievances/appeals, utilization management (UM) statusincluding but not limited to medical, dental, and vision plans

+ Provider search (PCP, specialty, and facility), focused on healthcare cost and quality, and present premier provider options, including but not limited to medical, dental, and vision plans

+ Support for spending accounts, pharmacy, and disability.

+ Aid with ordering durable medical equipment (DME)

+ Community resource search

+ **Coordinate issue resolution with providers,** **payers** **or 3rd parties for:**

+ Claims adjustments

+ Grievances and appeals submissions

+ Utilization management intake or status

+ Complex pharmacy inquiries

+ Complex spending account inquiries

+ Appointment availability

+ **Primary duties include but are not limited to:**

+ Research and documentation of issue resolutions.

+ Timely management of assigned queue tasks requiring research and resolution

+ Work closely with assigned Family Health Advocates to ensure timely resolution and follow up of tasks

Specific Skills/ Attributes:

+ Excellent multi-channel communication and problem-solving skills

+ Ability to communicate effectively in both voice and chat channels, including critical thinking skills, effective typing, grammar, and spelling skills.

+ Proficient in general office tool use and navigation (i.e.,Microsoft)

Qualifications:

+ High school / GED diploma

+ 2-yr associates degree in healthcare/health sciences OR equivalent experience in healthcare, preferably with research and resolving benefits and claims, OR held one or more of the following positions:

+ Health Guide/Advocate/Navigator

+ Claims Specialist/Processor

+ Medical Assistant

+ Medical Secretary/Clinic Manager

+ Medical Coder

+ Customer service experience within a healthcare contact center, provider office, or healthcare institution

+ Experience in successful resolution of high level/sensitive customer service issues.

Sharecare and its subsidiaries are Equal Opportunity Employers and E-Verify users. Qualified applicants will receive consideration for employment without regard to race, color, sex, national origin, sexual orientation, gender identity, religion, age, equal pay, disability, genetic information, protected veteran status, or other status protected under applicable law.

Sharecare is an Equal Opportunity Employer and doesn't discriminate on the basis of race, color, sex, national origin, sexual orientation, gender identity, religion, age, disability, genetic information, protected veteran status,or other non-merit factor.

**Job Description**

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Managers (PLMs) to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

**Responsibilities include, but are not limited to:**

+ Work allocation, staff development and performance appraisal.

+ Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

+ Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

+ Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.

+ Attend local Investigator Meetings if requested to.

+ Interface with GCTO partners on clinical trial execution.

+ Escalates site performance issues to CRM and Clinical Research Director CRD.

**People and Resource Management:**

+ Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

+ Support and resolve escalation of issues from CRAs.

+ Liaise with local HR and finance functions as required.

+ Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

+ Provides training, support and mentoring to the CRA to ensure continuous development.

+ Ensures CRA compliance to corporate policies, procedures and quality standards

Extent of Travel: up to 50%

**Qualifications, Skills & Experience**

**CORE Competency Expectations:**

+ Ability to work independently and in a team environment

+ Excellent people management, time management, project management and organizational skills

+ History of strong performance

+ Skills and judgment required to be a good steward/decision maker for the company

+ Fluent in Local Language and business proficient in English (verbal and written)

+ Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines

+ Expertise in and excellent working knowledge of core trial management systems and tools

**Behavioral Competency Expectations:**

+ High emotional intelligence

+ Strong leadership skills with proven success in people management

+ Excellent interpersonal and communication skills, conflict management

+ Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)

+ Influencing skills

**Experience Requirements:**

+ Minimum of 5 years´ experience within Clinical Research

+ Minimum of 3 years’ experience as CRA monitoring clinical trials

+ Line management experience preferred or at the minimum team leader experience

**Educational Requirements:**

+ Bachelor’s degree in science

\#eligibleforERP

ResearchandDevelopmentGCTO

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

**U.S. Hybrid Work Model**

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$139,600.00 - $219,700.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

**Travel Requirements:**

50%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

03/31/2025

***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

**Requisition ID:** R341453

The role is responsible for statistical activities in support of Medical Affairs and analyzing RWD, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed.

Summary of Key Responsibilities

+ Leads statistical support for post approval value evidence generation and reimbursement submissions

+ Conducts post hoc analysis to support publications and presentations

+ Reviews and authors abstract, manuscript, regulatory documents

+ Collaborates with cross-functional team to support observational studies

+ Develops statistical sections of study protocols and statistical analysis plans.

+ Collaborates with Data Management and Medical Research on design of eCRFs

+ Provides statistical guidance on conduct of ongoing studies.

+ Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs

+ Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.

+ Contributes to scientific articles, summarizing data collected in Alnylam studies.

+ Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed

Qualifications

+ PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience

+ Excellent written and oral communication and presentation skills

+ Strong knowledge of research methodology in HEOR (Health Economics and Outcomes Research) and pharmacoepidemiology

+ Ability to explain methodology and the consequences of decisions in lay terms

+ Significant, independent experience with statistical modeling of time-to-event outcomes (e.g., death, AE, hospitalization) including repeated or recurrent data and competing risk models

+ Advanced analytics techniques such as propensity score matching in analyzing RWD

+ Experience in survival analysis

+ Proficiency in SAS statistical procedures (e.g., PHREG, GENMOD, LOGISTIC, LIFETEST, MIXED)

+ Extensive experience programming in SAS

+ Extensive experiences working on data analysis with clinical studies database

+ Experience working on post-approval observational and clinical studies

+ Understanding of ICH GCP as well as general knowledge of industry practices and standards

+ Experiences in R programming language and other statistical software.

+ Experience with CDISC, including SDTM, ADaM, CDASH

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.