Sr Manager, Biostatistics

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 06, 2019
Ref
R0009721
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
We are seeking a highly motivated individual to join us as a Sr. Manager, Biostatistics. You will work with the Biostatistics team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director, Biostatistics.

The Sr. 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, with a particular emphasis on safety reporting and pharmacovigilance.

The Sr. manager, Biostatistics will be accountable for the validity and quality of all statistical input and deliverables for the assigned projects. Additionally, the Sr. manager, Biostatistics will provide consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.

Responsibilities (include but are not limited to):
  • Provides statistical expertise and input to drug development programs and safety surveillance 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.
  • Ability and experience to work with safety to develop appropriate tools and analysis strategies for safety surveillance
  • 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.

Requirements:
  • PhD in biostatistics, statistics, or mathematics
  • ≥ 4 years of industry working experience in biostatistics in clinical development and drug development experience
  • Can pull together highly effective teams and create a clear sense of direction.
  • 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 R, and/or SAS


*LI-RK1

IND-123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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