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.

Responsibilities

• 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.
  
  

Qualifications

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.