Senior Manager, Statistical Programming

Gilead Sciences • Raleigh, NC

4d • $146,200 - $219,120 • Hybrid

About The Position

Gilead is seeking a Senior Manager, Statistical Programming, to join its Statistical Programming–Analysis Programming team. The role collaborates with internal colleagues and external vendors to ensure efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of regulatory, scientific, and business objectives. The position is hybrid at either the Foster City, California, or Raleigh, North Carolina, location; it is not fully remote.

Requirements

• A BS degree in Biostatistics, Computer Science, or equivalent, and 8 or more years of pharmaceutical or biotechnology experience; or an MS degree in Biostatistics, Computer Science, or equivalent, and 4 or more years of such experience; or a PhD in Biostatistics, Computer Sciences, or equivalent, and 2 or more years of such experience.
• Excellent verbal and written communication and interpersonal skills.
• Solid analytical skills and advanced knowledge of statistics.
• A proven track record managing multiple time-sensitive and complex tasks.
• Thorough understanding of clinical trial design and reporting processes and regulatory reporting requirements, including electronic data submissions across multiple therapeutic areas, especially to FDA, PMDA, EMA, and other global agencies.
• Experience with integrated analysis activities for FDA and rest-of-world submissions and post-filing activities.

Nice To Haves

• A degree in Biostatistics, Computer Science, or equivalent.
• Eight or more years of pharmaceutical or CRO experience.
• Experience in oncology, hematology, virology, and inflammation.
• Knowledge of regulatory submissions.
• Hands-on experience with pivotal studies and regulatory submissions such as NDA, BLA, and MAA.
• In-depth understanding of clinical programming and/or statistical programming processes and standards.
• In-depth understanding of regulatory requirements relevant to statistical programming, such as GCP and ICH.
• Extensive experience with statistical programming using SAS, including development and use of SAS macros.
• Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
• Proven experience in complex, fast-turnaround programming activities.
• Excellent interpersonal, communication, problem-solving, and analytical skills.

Responsibilities

• Collaborate with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Generate or oversee programming deliverables, including tables, figures, and listings, for study reports and integrated summaries.
• Anticipate resource needs.
• Direct the design and/or coding of analysis files.
• Ensure programming and related documentation follow departmental procedures.
• Provide primary and secondary programming support as needed.
• Implement strategic initiatives.
• Interact with other departments to define and produce user-defined statistical reports, including ad hoc requests.
• Resolve study-related issues and conflicts within a therapeutic project.
• Build buy-in and support and negotiate timelines.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior