Senior Manager, Statistical Programming

Agenus Inc.

About The Position

Agenus is seeking an experienced Senior Manager, Statistical Programming to support statistical programming activities across oncology clinical development programs. This highly hands-on role develops, validates, and delivers clinical trial datasets, statistical analyses, and regulatory submission outputs. The Senior Manager works closely with Biostatistics, Clinical Development, Data Management, and external programming vendors to ensure the accuracy, quality, and timely delivery of programming activities. The role combines independent programming with vendor oversight in a small, collaborative, fast-paced biotech environment.

Requirements

Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific discipline, or equivalent relevant experience.
At least 7 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry, including substantial hands-on clinical trial programming.
Required oncology clinical trial programming experience, including developing and validating oncology efficacy and safety datasets and statistical outputs.
Advanced SAS expertise, including SAS/BASE, SAS/STAT, SAS/MACRO, and SAS/SQL, with 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.
Hands-on regulatory submission experience preparing and validating submission-ready datasets, TLFs, and supporting documentation in accordance with applicable regulatory standards and formats.
Strong understanding of FDA submission requirements and ability to independently produce compliant statistical programming deliverables.
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.
Experience overseeing CROs and external programming vendors, including technical review, quality assurance, issue resolution, and deliverable management.
Working knowledge of clinical trial design, statistical analysis plans, clinical data structures, and the drug development process.
Ability to manage multiple programming deliverables independently, troubleshoot complex technical issues, and adapt to changing study priorities.
Strong communication and cross-functional collaboration skills, including the ability to work effectively with statisticians, clinical teams, and external partners.
Self-motivated and detail-oriented, with the ability to take ownership of programming activities in a small, fast-paced biotech environment.

Nice To Haves

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.

Responsibilities

Independently develop, program, validate, and deliver oncology clinical trial outputs, including SDTM and ADaM datasets and tables, listings, and figures (TLFs).
Develop and validate oncology efficacy analyses, including RECIST-based tumor response assessments, ORR, PFS, OS, 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.
Prepare and validate regulatory submission-ready datasets, statistical outputs, and supporting documentation in accordance with CDISC standards, FDA requirements, and submission formats.
Use regulatory submission experience to ensure deliverables meet submission expectations and proactively identify and resolve formatting, validation, and compliance issues.
Perform advanced SAS programming, including developing 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 by reviewing specifications, independently validating deliverables, identifying discrepancies, and ensuring quality and timely delivery.
Partner with Biostatistics to interpret statistical analysis plans, develop programming specifications, and implement statistical methodologies and analysis requirements accurately.
Review 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 through independent quality control, validation, and documentation.
Collaborate with Clinical Development, Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, and other partners to support study milestones and regulatory objectives.
Contribute to improving statistical programming standards, SAS macros, SOPs, and quality control procedures.
Identify and resolve programming challenges, data inconsistencies, and risks to study deliverables and timelines.
Manage competing programming priorities across multiple studies while maintaining technical accuracy, accountability, and responsiveness.