Manager, Statistical Programming
About The Position
Kite Pharma, a Gilead company, is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological and solid malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. We are in search of a Manager, 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.
Requirements
- Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience
Nice To Haves
- Degree in Biostatistics/Computer Science or equivalent
- 6+ years of pharmaceutical/CRO experience
- Prior experience in oncology, hematology, and cell therapy is strongly preferred.
- Knowledge of long term follow up trial knowledge strongly preferred
- Hands-on experience in pivotal studies and/or 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 leading programming activities
- Excellent interpersonal, communication, problem solving, and analytical skills
Responsibilities
- Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting. Serves as project leader
- Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis
- Actively share experience and discuss possible process enhancements at programming meetings
- Recommends potential trainings
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
- Responsible for all programming activities within a therapeutic project or equivalent
- Implements strategic initiatives
- Able to lead and manage multiple concurrent projects
- Excellent verbal and written communication skills and interpersonal skills
- Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
- Ability to resolve study related issues and conflicts within a therapeutic project
- Can create buy-in and support and has the ability to negotiate timelines
- Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis
- Participates in SMT (Study Management Team) meeting as a representative of Programming group
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Manager
