Executive Director, Biometrics
The Executive Director of Biometrics will work with various teams at Rigel (Clinical Development, Medical Affairs, Marketing, Regulatory Affairs, Business Development) in the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide sound experimental design and data analysis expertise
- Author the protocol statistical sections and generate statistical analysis plans and study randomization 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
- Partner with Medical Affairs and Commercial to provide statistical support for publications (Posters, Manuscripts etc.)
- Manage the CROs 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 Data Science Solutions function on project teams and in cross functional meetings
- Supervise and lead the Data Science Solutions function (Biostats, Data Management, Statistical Programming) to respond to all statistical needs at Rigel
- Work closely with clinical sciences, clinical operations, regulatory, research, medical affairs, marketing, and business development to optimize the design and conduct of studies, to generate data (evaluation, interpretation and preparation of study results), to help in our interactions with regulatory agencies, partners, etc.
- Supervise CROs and contractors in Data Science Solutions
- Effectively promote innovation in Data Science Solutions, in cooperation with peers across all Rigel functions
KNOWLEDGE AND SKILL REQUIREMENTS:
- Ph.D. in Biostatistics, Statistics or closely related discipline with > 10 years of experience or MS with > 15 years of experience in the support of clinical studies in a pharmaceutical or biotech industry setting
- Must possess a comprehensive and detailed understanding of statistical experimental design and analysis, 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 Phase I-III clinical trials or studies
- Experience in immunology, hematology and or oncology studies preferred
- Experience with PLA/NDA/MAA submissions a must including ISS, ISE development
- Experience with regulatory interactions (FDA or EMA)
- Strong 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
- Strong interpersonal and effective communication (oral and written) skills
- Ability to efficiently manage multiple CROs
- PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Exposure to chemicals.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.