Senior Director, Statistical Programming

Bicara Therapeutics

full-time

Posted on: 1/6/2026

Location Type: Hybrid

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💰 $228,000 - $325,000 per year

About the role

Lead and manage statistical programming activities for clinical studies, ensuring high-quality deliverables and adherence to established timelines.
Allocate resources effectively and promote resource sharing across programs to meet organizational goals.
Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements, ensuring alignment with overall clinical and regulatory objectives.
Develop, validate, and maintain analysis datasets in compliance with CDISC standards, as well as tables, listings, and figures (TLFs) in accordance with regulatory guidelines and internal standards.
Review Statistical Analysis Plans (SAPs) to provide feedback, technical input, and strategic recommendations for successful execution.
Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA, PMDA), ensuring compliance with eCTD and electronic submission standards.
Build and maintain software-agnostic solutions and macros to automate repetitive tasks and improve programming efficiency.
Manage, mentor, and guide junior programmers, fostering their professional growth and ensuring consistent quality across deliverables.
Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis to enhance team capabilities and process efficiency.

MS degree in Statistics, Computer Science, Mathematics, or a related field
10+ years of progressive statistical programming experience in the pharmaceutical/ biotech industry
Oncology drug development experience in programming required, recent oncology experience preferred
Strong and proficient programming skill in SAS and/or R, thorough understanding of ICH Guidelines, relevant regulatory requirements, and CDISC standards
Familiarity with the expectations of regulatory agencies such as the FDA and EMA
Submission experience strongly preferred
Direct experience with NDA/BLA or other regulatory filings, including ISS or ISE
Direct supervisory experience and demonstrated experience in departmental resource allocation preferred
Ability to work effectively and efficiently both independently and as part of a cross-functional team
Strong attention to detail and awareness to escalate issues appropriately.

Tip: use these terms in your resume and cover letter to boost ATS matches.

statistical programmingSASRCDISC standardsNDABLAISSISEdata analysisprogramming strategies

leadershipmentoringresource allocationattention to detailcollaborationcommunicationproblem-solvingindependenceteamworkstrategic recommendations