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Manager, Biomarker Statistical Programming
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thehivecareers.coRaleigh, NC, United StatesManager, Biomarker Statistical Programming
Gilead Sciences, Inc.Raleigh, North Carolina, United States- [job_card.full_time]
Description
The Manager Statistical Programming leads and oversees biomarker statistical programming activities for clinical development projects, partnering cross‑functionally to deliver high‑quality analyses and reports while managing resources, ensuring compliance with standards, and providing hands‑on programming and team leadership.
Job Responsibilities
- Lead biomarker data analysis projects, data integration and standardization.
- Provides consistency and quality assurance on biomarker programming activities.
- Generates the production of statistical output (e.g., tables, listings) for study reports and integrated summaries.
- Independently identifies issues in the analysis from previous experience and knowledge.
- Collaborates with Research Data Scientists, Biostatistics, Clinical Data Management, and Biomarker Scientists on analysis datasets and reporting. Participates in cross functional team meeting as a representative of Biomarker Stat Programming group.
- Provides trainings to junior programmers in biomarker statistical programming team.
- Lead and implement tool development activities within biomarker statistical programming group and collaborates in cross functional tool development.
- Responsible for all biomarker statistical programming activities within a therapeutic area.
Basic Qualifications
PhD degree in Biostatistics, Computer Sciences or equivalent and 0+ years of relevant experience
OR
MS degree in Biostatistics, Computer Science or equivalent and 4+ years of relevant experience
OR
BS degree in Biostatistics, Computer Science or equivalent and 6+ years of relevant experience
Preferred Qualifications
- 5+ years of pharmaceutical or CRO experience
- Experience in bioinformatics, medical research at cancer & tumor immunology, immunogenicity & proteomics fields.
- Experience in clinical trials statistical programming and data analysis, with great understanding of clinical trial development in use of Biomarker from Phase I to IV
- Proficiency in SAS. R/python. Advanced SAS and R programming experience preferred.
- Knowledge of clinical trials FDA guideline, clinical trials related regulatory requirements and terminology.
- Thorough understanding of CDISC standards, extensive experience in creating SDTM and ADaM datasets
- Oncology, hematology, or cell therapy experience strongly preferred
- Self motivated to work in a fast-paced dynamic team.
- Excellent communication, interpersonal & organizational skills
- Can create buy-in and support. Has capability in resource anticipation and allocation. Has the ability to negotiate timelines
The salary range for this position is:
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.