Senior Manager, Biostatistics
Clinical Development | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2.5 billion (NASDAQ: KITE).
The Senior Manager, Biostatistics will be responsible for all statistical aspects within a clinical development program, including statistical input into the clinical development plan, support of translational research, design and analysis of clinical trials, interaction with regulatory authorities and key opinion leaders, and management and oversight of outsourcing partners. The Senior Manager, Biostatistics will be accountable for the validity and quality of all statistical input and deliverables for the assigned projects. Additionally, the Senior Manager, Biostatistics will provide consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality. This position reports to the Senior Director of Biostatistics.
Responsibilities include, but are not limited to:
- Provides statistical expertise and input to drug development programs, including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value.
- Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results.
- Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.
- Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables.
- Establishes and maintains effective working relationships with vendors and project teams.
- Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields.
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
- Perform other duties as required.
- MS or PhD in biostatistics, statistics, or mathematics
- 6+ years experience in biostatistics in clinical development and drug development experience in oncology
- Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
- Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
- Working knowledge of SAS and / or R
- Ability to communicate and work independently with scientific/technical personnel
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.