Manager, Statistical Programming

Role 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. We are in search of a Manager, Statistical Programming to join our team!

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 shares experience and discusses 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.

Qualifications

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience.

Requirements

• 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.

Benefits

• The salary range for this position is: $133,195.00 - $172,370.00.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.