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.
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.
- 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