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Director, Biostatistics at Priovant Therapeutics
, , -
Full Time

Start Date

Immediate

Expiry Date

02 Feb, 26

Salary

0.0

Posted On

04 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Biostatistics, Clinical Studies, Regulatory Submissions, Statistical Leadership, Project Management, Communication Skills, Regulatory Trends, Policy Development, Autoimmune Diseases, Data Management, Programming, CRO Management, Team Coordination, Entrepreneurial Environment

Industry

Biotechnology Research

Description
Overview Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Director of Biostatistics is a core member of the Biometrics Team for Priovant who supports the design, analysis, interpretation and reporting of clinical studies, regulatory and payer submissions. This position reports to the Vice President of Biometrics. Responsibilities Develop, lead, and serve as the primary point of contact for biostatistics for assigned new and ongoing clinical studies Alongside other functional leads, contribute to the formation of a regulatory strategy for NDA-enabling activities Ensure timely programming and delivery of ad hoc requests to clinical colleagues Provide oversight of deliverables from CROs and manage relationship with biostatistics and biostatistical programming partners at CROs Serve as point of contact for ongoing NDA-enabling workstreams with external collaborators Lead and coordinate biometric activities within data management and programming teams Contribute to the development of relevant policies and procedures Qualifications Advanced degree (PhD or MS) in relevant field and 6+ years of post-graduate statistics experience in clinical-stage drug development, at least 3 of which must be at biopharmaceutical companies Experience at small/midsize biotech strongly preferred Experience with statistical leadership on regulatory submissions Effectiveness with managing multiple projects Excellent oral and written communication skills Thorough understanding of regulatory and industry trends Experience developing policies and SOPs Prior experience in autoimmune diseases or related therapeutic areas preferred Ability to work in fast-paced and entrepreneurial environments
Responsibilities
The Director of Biostatistics will develop, lead, and serve as the primary point of contact for biostatistics for assigned clinical studies. This role includes contributing to regulatory strategy and managing relationships with CROs.