Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. 

 At Replimune, we live by our values: 

United: We Collaborate for a Common Goal. 

Audacious: We Are Bold and Innovative. 

Dedicated: We Give Our Full Commitment. 

Candid: We Are Honest With Each Other. 

People are at the center of everything we do, and when it comes to our employees, we make it personal.  With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.  

Join us, as we reshape the future. 

Replimune’s mission is to discover and deliver a new generation of cancer treatments called oncolytic immunotherapies. Oncolytic viruses combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, and generating a robust patient-specific, systemic anti-tumor immune response. Oncolytic immunotherapy is expected to strengthen the effectiveness of immune checkpoint blockade and become the second cornerstone of immune-oncology approaches, moving beyond the incremental improvement in cancer treatment to help more patients overcome their disease.

Summary of job description:

The Manager, Programmer is responsible for mapping analysis ADaM dataset, creating and validating tables, listings and figures from SDTM datasets for Phase I – III oncology clinical trials. 

This position has flexibility to be located in the Woburn, MA Headquarters or remote with the ability to travel 10% to the Woburn office.

• Collaborate with internal and external functions to plan and execute programming deliverables.
• Develop and execute statistical analysis and reporting deliverables in a timely and high-quality manner. 
• Review or author SDTM and ADaM datasets specifications for datasets programming.
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for ADaM datasets, fit-for-purpose analysis, and TLFs.
• Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
• Provide programming support for adhoc analysis and for preparation of publications, including manuscripts and posters etc.
• Review key study-related documents including but not limited to SAP, annotated case report form, data management plan, database specifications, EDC data structures specs
• Participates in the development of overall objectives and influences long-term goals of the team.
• Other duties as assigned.

Educational requirements:

• Bachelor’s degree in Life Science, Statistics, Mathematics, or Computer Sciences is required. Master’s degree preferred

Experience and skill requirement:

• Minimum of 5 years of SAS programming experience within a Pharma/Biotech or CRO
• Solid SAS programming skills and experience with CDISC, SDTM, ADaM and Pinnacle 21. Good programming skills in MACRO is needed.
• Experience in the analysis of complex oncology clinical trial data. Knowledge of immuno-oncology is a plus
• Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH)
• Strong knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.)
• Prior experience filing a BLA or NDA preferred.
• Ability to manage multiple initiatives and shift priorities within a small company environment.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.