At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
For patients, for each other, and for the future of science, we’re in. Are you?
About the Role:
We’re looking for an Associate Director, Programming to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Programming, you’ll provide technical leadership as the Program Lead for an assigned compound and ensure adequate programming support for the studies of that compound as well as successful implementation of programming strategies and efficient execution of analyses. You will collaborate with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development, as well as with external vendors. You’ll also oversee contractors and coach junior team members.
What You'll Do:
In this role, you’ll have the opportunity to lead the programming activities as the Program Lead Programmer of a compound and related oversight activities ensuring quality and timeliness. You’ll also:
Act as a Study Lead Programmer for a study (or studies) within the assigned compound
Set the overall programming strategy, tasks, prioritization, and resources within assigned compound
Provide program-level programming leadership and support to clinical development teams
Provide hands-on programming support to assigned studies and exploratory analyses, both internally and in response to regulatory agencies’ ad-hoc requests
Ensure quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and Work Instructions
Lead process improvement initiatives
Provide technical guidance to Insmed programmers, contractors, and vendors around programming conventions, standards, practices, and specifications to ensure integrated computing solutions
Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Contribute to the creation, maintenance, and validation of internal standards for programming tools, outputs, and macros
Who You Are:
You have a Master’s degree in Biostatistics, Statistics, Computer Science, Data Science, or a related field along with 6 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development.
OR
You have a Bachelor's degree in Biostatistics, Statistics, Computer Science, Data Science, or a related field along with 10 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development.
You are or you also have:
Proficiency in R, with familiarity with the pharmaverse and tidyverse ecosystems for clinical data analysis and reporting
Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval
Experience in global regulatory submissions
Extensive knowledge of and experience with CDISC standards including SDTM and ADaM dataset specifications and define.xml
Able to adapt quickly to the changing needs of the organization
Ability to manage multiple studies within a program in a fast-paced environment and experience in project management
Collaborative, proactive problem-solver with sound decision-making, resourceful and effective both independently and in cross-functional team environments.
Experience with SAS
Excellent verbal and written…