Senior Manager, Statistical Programming

The Role:

Agenus is seeking an experienced Senior Manager, Statistical Programming to support statistical programming activities across our oncology clinical development programs. This is a highly hands-on role responsible for developing, validating, and delivering high-quality clinical trial datasets, statistical analyses, and regulatory submission outputs.

The Senior Manager will work closely with Biostatistics, Clinical Development, Data Management, and external programming vendors to ensure the accuracy, quality, and timely delivery of programming activities. The ideal candidate brings strong oncology programming experience, direct involvement in regulatory submissions, and the technical expertise to independently develop submission-ready deliverables. This individual must be comfortable balancing hands-on programming with vendor oversight while working in a small, collaborative, fast-paced biotech environment.

In the role you will:

• Independently develop, program, validate, and deliver statistical programming outputs for oncology clinical trials, including SDTM and ADaM datasets, tables, listings, and figures (TLFs).
• Develop and validate oncology efficacy analyses, including RECIST-based tumor response assessments, objective response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and other time-to-event endpoints.
• Program and validate oncology safety analyses, including adverse events, immune-mediated adverse events, treatment exposure, laboratory data, and integrated safety assessments.
• Independently prepare and validate regulatory submission-ready datasets, statistical outputs, and supporting documentation, ensuring compliance with CDISC standards, FDA requirements, and established submission formats.
• Apply direct regulatory submission experience to ensure programming deliverables meet submission expectations, proactively identifying and resolving formatting, validation, and compliance issues.
• Perform advanced SAS programming, including development of complex analysis datasets, statistical outputs, reusable macros, and programming utilities.
• Provide hands-on programming support for integrated safety and efficacy analyses, interim analyses, clinical study reports, and regulatory submissions.
• Oversee CROs and external statistical programming vendors, including reviewing programming specifications, independently validating deliverables, identifying discrepancies, and ensuring quality and adherence to timelines.
• Partner with Biostatistics to interpret statistical analysis plans (SAPs), develop programming specifications, and ensure accurate implementation of statistical methodologies and analysis requirements.
• Review key clinical study documents, including case report forms, data management plans, database specifications, and clinical study reports, to identify programming requirements and potential data issues.
• Ensure accuracy, consistency, traceability, and reproducibility of programming outputs through independent quality control, validation, and appropriate documentation.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, and other cross-functional partners to support clinical study milestones and regulatory objectives.
• Contribute to the development and improvement of statistical programming standards, SAS macros, SOPs, and quality control procedures.
• Proactively identify and resolve programming challenges, data inconsistencies, and potential risks to study deliverables and timelines.
• Manage competing programming priorities across multiple studies while maintaining a high level of technical accuracy, accountability, and responsiveness.

Qualifications: About you

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific discipline, or equivalent relevant experience.
• Minimum of 7+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry, with substantial hands-on clinical trial programming responsibilities.
• Required oncology clinical trial programming experience, including direct involvement in developing and validating oncology efficacy and safety datasets and statistical outputs.
• Advanced SAS programming expertise, including SAS/BASE, SAS/STAT, SAS/MACRO, SAS/SQL, and experience developing complex analysis datasets, statistical outputs, and reusable programming tools.
• Expert knowledge of CDISC standards, including SDTM and ADaM, with hands-on experience developing, reviewing, and validating datasets, specifications, and derivations.
• Demonstrated hands-on regulatory submission experience, including preparing and validating submission-ready datasets, TLFs, and supporting documentation in accordance with applicable regulatory standards and required formats.
• Strong understanding of FDA submission requirements and the ability to independently produce compliant statistical programming deliverables without extensive direction.
• Experience programming oncology efficacy endpoints, including tumor response assessments, survival analyses, and other time-to-event endpoints.
• Experience with independent programming validation, quality control, and reconciliation of clinical trial datasets and statistical outputs.
• Strong experience overseeing CROs and external programming vendors, including technical review, quality assurance, issue resolution, and management of deliverables.
• Working knowledge of clinical trial design, statistical analysis plans, clinical data structures, and the drug development process.
• Ability to independently manage multiple programming deliverables, troubleshoot complex technical issues, and adapt to changing study priorities.
• Strong communication and cross-functional collaboration skills, with the ability to work effectively with statisticians, clinical teams, and external partners.
• Self-motivated, detail-oriented, and comfortable taking ownership of programming activities in a small, fast-paced biotech environment.

Preferred Qualifications

• Experience in immuno-oncology clinical development, including immune-mediated adverse event analyses and adverse events of special interest.
• Experience supporting late-stage oncology clinical trials, including Phase 3 and registrational studies.
• Experience supporting integrated summaries of safety (ISS) and efficacy (ISE) for regulatory submissions.
• Experience with regulatory submission documentation and validation tools, including define.xml, reviewer guides, and Pinnacle 21.
• Experience with oncology-specific ADaM datasets, including ADRS and ADTTE, and efficacy visualizations such as Kaplan-Meier curves and waterfall plots.
• Proficiency or working knowledge of R and/or Python.
• Experience developing SAS macros, automation tools, and programming efficiencies within a clinical development environment.

Originally posted on Himalayas