Job Description
We are in search of an Associate Director _**, Statistical Programming**_ to join our team! 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.
This is a HYBRID position at our Foster City, CA OR Raleigh, NC locations. This is NOT a fully remote position.
Job 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, listings) for study reports and integrated summaries.
- Anticipates resource needs.
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Directs the design and/or coding of analysis files.
- Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions for multiple therapeutic areas with FDA, PMDA, and other global agencies.
- Has extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom preparation, and inspections.
- Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
- Has the proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project.
- Proven track record as a key resource on multiple, time-sensitive, and complex tasks
- Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.
- Manages critical deadlines, demonstrates ability to resolve issues, and ensures tasks will be completed within designated timeframe.
- Identifies and leads strategic initiatives for the programming group.
Basic Qualifications:
- BS degree in Biostatistics/Computer Science or equivalent and 10+ years’ experience in pharma/biotech -OR -
- MS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech –OR -
- PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech
Preferred Qualifications:
- Degree in Biostatistics/Computer Science or equivalent
- 10+ years of pharmaceutical/CRO experience
- Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred.
- Submission knowledge is strongly preferred.
- Extensive hands-on experience in pivotal studies, integrated analysis, and other regulatory submission related activities.
- 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
