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Bicara Therapeutics · 6 days ago

(Senior) Director, Statistical Programming

Boston, Massachusetts, United States

Full-time

Hybrid

Director/Executive

$228K/yr - $325K/yr

10+ years exp

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. They are seeking an experienced Senior Director of Statistical Programming to lead programming functions supporting oncology clinical programs, overseeing statistical programming activities and collaborating with cross-functional teams to ensure 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

Statistical ProgrammingSASROncology ExperienceCDISC StandardsRegulatory SubmissionsNDA/BLA ExperienceTeam LeadershipAttention to DetailCross-Functional Collaboration

Required

MS degree in Statistics, Computer Science, Mathematics, or a related field

10+ years of progressive statistical programming experience in the pharmaceutical/ biotech industry

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

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

Oncology drug development experience in programming required, recent oncology experience 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.

Founded in 2020

Cambridge, Massachusetts, USA

51-200 employees