(Senior) Director, Statistical Programming

Bicara Therapeutics • Boston, MA

4d • Hybrid

About The Position

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.

Requirements

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees