This Programmer/Manager or Sr. Programmer/Senior Manger position is responsible for mapping SDTM and ADaM datasets, creating and validating tables, listings and figures from ADaM datasets for Phase I – III oncology clinical trials. 

This position can be based either in our Woburn office or be a remote role

• • Our Woburn location welcomes hybrid work!  Local candidates are expected to be on-site 2 days per week.
  • Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 6-8 weeks or as business needs require.

Key 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 responsibilities

• 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 requirements:

• 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 skill 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.

Location Requirements:

This position can be based either in our Woburn office or be a remote role

• Our Woburn location welcomes hybrid work!  Local candidates are expected to be on-site 2 days per week.
• Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 6-8 weeks or as business needs require.

Replimune is an equal opportunity employer.

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