The Director of Biostatistics will work with clinical development teams in the conduct of clinical studies and in the evaluation, interpretation and preparation of study results. Rigel is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Author and review statistical analysis plans and study randomization schemes as needed
- Review and sign off on relevant study documents and data management and programming deliverables
- Prepare and review mockup tables, figures and listings. Determine analysis and data presentation specifications for CRO programmers and statisticians
- Provide verification and QA reviews on final tables, figures and listings
- Manage the CRO’s performing analysis, interpret study results, and collaborate with medical and biostatistics staff to produce safety monitoring reports, interim and final reports, and publications
- Represent the biostatistics function on project teams and in cross functional meetings
- Work with biostatistics and clinical staff at Rigel and CRO’s to define datasets and analyses for the Integrated Summary of Safety and Efficacy as appropriate. Interpret results of integrated summary analyses and collaborate with medical and biostatistics staff to produce reports for the application to regulatory agencies
- Effectively promotes innovation in Biostatistics and in cooperation with peers across all Rigel functions
- Greater aptitude for identifying productive new technological initiatives/directions.
- Demonstrated ability to successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for optimal advancement of all goals and objectives
- Demonstrated knowledge of field; proven instrumental in attracting and retaining employees
KNOWLEDGE AND SKILL REQUIREMENTS:
- MS with 12 years of experience or Ph.D. in Biostatistics, Statistics or closely related discipline with 10 years of experience in the support of clinical studies in a pharmaceutical or biotech industry setting
- Must possess understanding of statistical experimental designs and analyses, clinical trial requirements and statistical software packages such as SAS
- Understanding of regulatory guidelines that affect statistical deliverables
- Experience with the management and statistical analysis of data obtained from clinical trials
- Experience in immunology, hematology and or oncology studies preferred
- Experience with NDA/MAA submissions a must including ISS and ISE development
- Direct dealings with regulators
- Strong interpersonal and effective communication (oral and written) skills.
- Ability to efficiently manage multiple CRO’s
Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.
All individuals are encouraged to apply