Manager, Biomarker Statistical Programming

Gilead Sciences • Parsippany, NJ

1d

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job 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.

Requirements

• 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

Nice To Haves

• 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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree