Manager, Statistical Programming

Job Description

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.

Responsibilities (include but are not limited to):

• 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

Basic Qualifications:

• BS degree in Biostatistics/Computer Science or equivalent and 6 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

Preferred Qualifications:

• Degree in Biostatistics/Computer Science or equivalent
• 6+ years of pharmaceutical/CRO experience
• Prior experience in oncology, hematology, cell therapy 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