Director, Biostatistics
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Job Description
Director of Biostatistics overseeing statistical aspects of programs at 4D Molecular Therapeutics. Mentoring statisticians and ensuring compliance with clinical standards and methodologies.
Responsibilities:
- Provides strategic statistical input to and oversees all statistical aspects of assigned programs;
- Drives cross-functional collaboration and decision making for program(s);
- Oversees the performance of Contract Research Organizations (CROs);
- Develop and mentor other statisticians.
- Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program.
- Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans.
- Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
- Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
Requirements:
- M.S. required
- PhD preferred
- 8+ years of pharmaceutical industry experience with a PhD, or 10+ years with an MS.
- Hands-on familiarity with common and advanced statistical methodology.
- Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
- Strong knowledge of SAS programming concepts and techniques in the pharmaceutical;
- Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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