Manager, Statistical Programming
Gilead Sciences
Summary
Statistical Programming– Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.
Job description
Key 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.
- 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.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Analytical skills with advanced knowledge of statistics
- Proven track record on multiple, time-sensitive, and complex tasks
- Has a thorough understanding of clinical trials design and reporting processes, as well as regulatory reporting requirements including electronic data submissions, especially with FDA, PMDA, EMA, and other global agencies.
- Experience with integrated analysis activities for FDA and rest of world submissions plus their post-filing activities.
- Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
- Has the ability to resolve study related issues and conflicts within a therapeutic project.
- Can create buy-in and support and can negotiate timelines.
Basic Qualifications
- BS degree in Biostatistics/Computer Science or equivalent and 7+ years’ experience in pharma/biotech
- MS degree in Biostatistics/Computer Science or equivalent and 3+ years’ experience in pharma/biotech
- PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech
Preferred Qualifications
- Degree in Biostatistics/Computer Science or equivalent
- 7+ years of pharmaceutical/CRO experience
- Prior experience in oncology, hematology, virology, or 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)
- Proven experience in complex and fast turnaround programming activities
- Excellent interpersonal, communication, problem solving, and analytical skills
Requirements
- BS degree in Biostatistics/Computer Science or equivalent and 7+ years’ experience in pharma/biotech
- MS degree in Biostatistics/Computer Science or equivalent and 3+ years’ experience in pharma/biotech
- PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech
- Excellent verbal and written communication skills and interpersonal skills
- Analytical skills with advanced knowledge of statistics
- Proven track record on multiple, time-sensitive, and complex tasks
- Thorough understanding of clinical trials design and reporting processes
- Understanding of regulatory reporting requirements including electronic data submissions (FDA, PMDA, EMA)
- Experience with integrated analysis activities for FDA and rest of world submissions plus post-filing activities
- Ability to interact with other departments to define and produce user-defined statistical reports
- Ability to resolve study related issues and conflicts within a therapeutic project
- Ability to create buy-in and support and negotiate timelines
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Paid time off
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.