(Senior) Director, Statistical Programming

Position Overview

Bicara is seeking an experienced (Senior) Director, Statistical Programming to lead the programming function supporting Bicara's oncology clinical programs. This individual will oversee and support statistical and clinical programming activities for all development programs and is responsible for planning, monitoring, organizing and reviewing activities of statistical programming team by working with Biostatistics, Data Management, and other functional stakeholders. The position serves as an in-house expert for statistical programing and data standards, assists the team to develop functional strategies, and drives the development and continuous improvement of procedures, training and standards. The ideal candidate thrives in a dynamic, fast-paced environment and is eager to contribute both technically and strategically to program success. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

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

Qualifications

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 elevate issues appropriately

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’slead program,ficerafuspalfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF‑β). Through this dual-targeting mechanism,ficerafuspalfa has the potential to exert potent anti‑tumor activity by simultaneously blocking both cancer cell‑intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF‑β signaling within the tumor microenvironment. Ficerafuspalfa is being developed in head and neck squamous cell carcinoma, where thereremainsa significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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