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.

Responsibilities

• 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

Requirements

• Master's degree in Biostatistics, Statistics, Computer Science, Data Science, or related field with 6 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development; OR Bachelor's degree in same fields with 10 years of such experience
• 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
• Ability 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

Skills

• Experience with Python (nice to have)
• R package development experience (nice to have)

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement and access to Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with competitive company match, annual equity awards, and participation in Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Pay

$164,000.00–$213,000.00 Annual

Schedule

Fully remote role; can be performed from anywhere while staying connected to the Insmed team and community. Occasional travel (approximately 15%) for team meetings or events.