Kite Pharma, Inc. is looking for a Manager, Statistical Programming to lead programming activities and ensure the high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries. You will serve as a project leader, interacting with internal and external teams to meet project deliverables and timelines.
What You'll Do
- Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Generate or oversee the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
- Actively share experience and discuss possible process enhancements at programming meetings.
- Ensure programming and corresponding documentation is completed in a manner consistent with departmental procedures.
- Be responsible for all programming activities within a therapeutic project or equivalent.
- Implement strategic initiatives.
- Lead and manage multiple concurrent projects.
- Resolve study related issues and conflicts within a therapeutic project.
- Create buy-in and support and negotiate timelines.
- Interact with Clinical Data Science, Clinical Development and Regulatory Affairs groups frequently.
- Participate in SMT (Study Management Team) meeting as a representative of the Programming group.
What We're Looking For
- BS degree in Biostatistics/Computer Science or equivalent and 7 years of experience in pharma/biotech.
- MS degree in Biostatistics/Computer Science or equivalent and 4 years of experience in pharma/biotech.
- PhD degree in Biostatistics/Computer Sciences or equivalent and 2 years of experience in pharma/biotech.
- 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.
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
Nice to Have
- 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).
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven experience in leading programming activities.
- Excellent interpersonal, communication, problem solving, and analytical skills.
Technical Stack
- SAS
Team & Environment
Works within Biometrics and Clinical Data Science, interacts with Clinical Development and Regulatory Affairs.
Benefits & Compensation
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
- Compensation: $133,195.00 - $172,370.00
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
