Replimune, Inc.

AD Programming

Job Locations US-MA-Woburn
ID
2022-1188
Category
Biometrics
Position Type
Regular Full-Time

Overview

Summary of job description:
This Associate Director Programmer/Senior Manager position is responsible for mapping analysis ADaM dataset,
creating and validating tables, listings and figures from SDTM datasets for Phase I – III oncology clinical trials

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 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 12 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.

 

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