Bicara Therapeutics · 1 day ago
(Senior) Director, Statistical Programming
Boston
Full-time
Hybrid
Director/Executive
$228K/yr - $235K/yr
10+ years expBicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. The Senior Director of Statistical Programming will lead the programming function supporting oncology clinical programs and oversee statistical programming activities to ensure compliance and high-quality deliverables.
BiopharmaBiotechnologyLife ScienceOncologyTherapeutics
Responsibilities
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
Qualification
Required
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
Direct experience with NDA/BLA or other regulatory filings, including ISS or ISE
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
Preferred
Submission experience strongly preferred
Direct supervisory experience and demonstrated experience in departmental resource allocation preferred
Company
Bicara Therapeutics
Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$313MKey Investors
Biocon
2024-09-13IPO
2023-12-12Series C· $165M
2023-03-06Series B· $108M
Leadership Team
Claire Mazumdar
Chief Executive Officer
David Raben
CMO, Bicara Therapeutics
Recent News
2026-01-13
2026-01-12
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