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Replimune, Inc. Sr. Manager, Programing in Framingham, Massachusetts

Summary of job description:

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.

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.

*Please note: Candidates must be local or open to relocating as remote is not an option for some roles.

Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn office

Framingham Location: Please Note for Framingham roles 5 day onsite expectation

Replimune is an equal opportunity employer.

Replimune now requires COVID vaccination disclosure for all US employees

Requisition ID: 2022-1191

External Company Name: Replimune, Inc.

External Company URL: replimune.com

Street: 33 New York Avenue

Telecommute: Yes

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