Sr. SAS Programmer
Replimune Group
Sr. SAS Programmer
- ID
- 2024-1516
- Category
- Biostatistics and Programming
- Position Type
- Regular Full-Time
Overview
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.
Responsibilities
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.
Qualifications
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.
Replimune now requires COVID vaccination disclosure for all US employees.
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