Director - Senior Director, Statistical Programming

$215k - $270k

Bicycle Therapeutics

Bicycle Therapeutics seeks a Director or Senior Director of Statistical Programming to provide strategic and technical leadership for the statistical programming function supporting clinical development programs. The role involves managing a programming team, overseeing CRO partnerships, ensuring regulatory compliance, and driving operational excellence across all data and analysis deliverables.

Responsibilities

Provide strategic leadership and accountability for all statistical programming deliverables and compliance
Serve as senior technical expert on CDISC standards, programming methodologies, and data submission strategies
Partner with Biometrics Lead to define long-term vision for programming function and resource planning
Develop and optimize SOPs, tools, and workflows to enhance efficiency and quality
Lead, coach, and mentor programming team while setting clear strategic priorities aligned with organizational goals

Requirements

Deep expertise in statistical programming from significant biotech or pharmaceutical experience
Proven track record leading programming strategy for clinical development programs, preferably oncology
Expert-level SAS programming and CDISC standards (SDTM/ADaM) knowledge
Extensive experience preparing data for regulatory submissions (NDA/BLA)
Substantial CRO and external vendor management experience with technical oversight
Demonstrated leadership ability to mentor programmers and influence cross-functional partners

Compensation: $215,000 - $270,000 base

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Vacancy posted 7 days ago

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