Senior/Principal Statistical Programmer

Position Overview:

Bicara is seeking an experienced Senior/Principal Statistical Programmer to support statistical programming activities for clinical studies. This role requires strong SAS programming skills and expertise in CDISC standards (SDTM, ADaM) to ensure high-quality, submission-ready datasets and outputs. The ideal candidate will have a solid understanding of clinical trial data, experience managing programming activities, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities: 

• Serve as the lead statistical programmer on clinical studies, overseeing programming activities both internally and externally.
• Manage and collaborate with external vendors and CROs to ensure high-quality deliverables.
• Develop, validate, and maintain SAS programs for data manipulation, analysis, and reporting.
• Create and validate CDISC-compliant datasets (SDTM, ADaM) and define.xml files for regulatory submissions.
• Generate and/or validate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and publications.
• Collaborate closely with biostatistics, data management, clinical, and safety teams to ensure data quality and integrity.
• Provide programming support for regulatory interactions and submissions.
• Contribute to the development and implementation of standardized programming processes, macros, and automation tools to enhance efficiency.
• Ensure compliance with Good Programming Practices (GPP), ICH guidelines, and company SOPs.
  

Qualifications: 

• Master’s degree or above in Biostatistics, Statistics, Mathematics, Computer Science, or a related field.
• 5 years of relevant statistical programming experience using SAS; knowledge of R is a plus.
• At least 2 years of oncology experience in a clinical trial setting.
• Strong knowledge of CDISC standards (SDTM, ADaM), define.xml, and Pinnacle 21 validation tools.
• Experience working with electronic data capture (EDC) systems such as Medidata Rave.
• Solid understanding of the drug development process and clinical trials.
• Exceptional attention to detail with the ability to manage multiple competing priorities effectively.
• Strong planning, time management, and problem-solving skills.
• Good communication and collaboration skills in a cross-functional team environment.  

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, 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, ficerafusp alfa 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. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a 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.