Biostats Consultant 1178785
Job Scope & Purpose:
Our Cambridge based client is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. They are seeking to hire a Biostats Consultant to lead statistical and programming activities in Phase I-III clinical studies. This role can be remote.
Primary Job Responsibilities:
- Lead statistical and programming activities in ISS/ISE to support BLA
- Perform, advise, and review protocol development, sample size calculation, protocol and CRF review
- Ensure the accurate programming of SAS clinical data extracts and data displays
- Provide statistical input into and perform review of SAPs, table shells, programming and table specifications, TLFs, and statistical sections for integrated reports, statistical sections of CSRs, database design, validation checks and critical data, and data review
- Advise on regulatory issues including integrated summaries of efficacy and safety
- Perform statistical analyses, including hypothesis testing and modeling.
- Provide input to project timelines, and ensure that project timelines for biostatistics deliverables are met by internal and external clients.
Primary Job Requirements:
- BS/MS degree or advanced degree in biostatistics/statistics (or similar) and 6+ years of clinical research and drug development experience.
- Broad and thorough understanding of statistical principles, particularly with respect to statistical methodology with observational/real world data
- In-depth knowledge of applicable clinical research regulatory requirements
- Advanced knowledge of statistical methods , especially that apply to GI/Infectious disease focused clinical trials
- Strong working knowledge of SAS programming
- Prior BLA experience is desired
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