Associate Director, Programming

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 communication skills, highly organized with attention to detail, clarity, and accuracy
• Forward-looking thinker who actively identifies opportunities and proposes solutions

Nice to have (but not required): Experience with Python, and R package development experience

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. This role requires occasional travel (approximately 15%).