Senior Manager, Statistical Programming
Gilead Sciences · San Francisco, CA · Today
Writing$169k–$219k/yrFull-time
About the role
We are in search of a Senior Manager, Statistical Programming to join our team!
Responsibilities
- Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Generates or oversees the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries.
- Anticipates resource needs.
- Directs the design and/or coding of analysis files.
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Provides primary and secondary programming support as needed.
- Implements strategic initiatives.
Requirements
- Excellent verbal and written communication skills and interpersonal skills are required.
- Solid analytical skills with advanced knowledge of statistics.
- Prior experience in oncology, hematology, virology, and inflammation is strongly preferred.
- Knowledge of submission knowledge strongly preferred.
- Hands-on experience in pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.).
- In-depth understanding of clinical programming and/or statistical programming processes and standards.
- In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
Qualifications
- BS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech -OR-
- MS degree in Biostatistics/Computer Science or equivalent and 4+ years’ experience in pharma/biotech -OR-
- PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech
Skills
- Experience with integrated analysis activities for FDA and rest of world submissions plus their post-filing activities.
- Ability to resolve study related issues and conflicts within a therapeutic project.
- Ability to create buy-in and support and can negotiate timelines.
Benefits
- The Salary Range For This Position Is Bay Area: $169,320.00 - $219,120.00.
- Raleigh: $146,200.00 - $189,200.00.
- Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.