Associate Director, Programming
About The Position
Insmed is seeking an Associate Director, Programming to provide technical leadership as the Program Lead for an assigned compound. The role ensures adequate programming support for the compound’s studies, successful implementation of programming strategies, and efficient execution of analyses. The Associate Director collaborates with colleagues in Biometrics, Clinical Operations, Regulatory, and Clinical Development, as well as external vendors, and oversees contractors while coaching junior team members. The position leads programming activities and related oversight for a compound, with responsibility for quality and timely delivery. It also serves as Study Lead Programmer for one or more studies within the compound, provides hands-on programming support for studies and exploratory analyses, and responds to ad-hoc regulatory agency requests. The role is fully remote and requires occasional travel, approximately 15% of the time.
Requirements
- Master’s degree in Biostatistics, Statistics, Computer Science, Data Science, or a related field and 6 years of experience in statistical programming and analytics within pharmaceutical or biotechnology clinical development; alternatively, a bachelor’s degree in one of those fields and 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 changing organizational needs.
- Ability to manage multiple studies within a program in a fast-paced environment, with project management experience.
- Collaborative and proactive problem-solving, sound decision-making, resourcefulness, and effectiveness working independently and in cross-functional teams.
- Experience with SAS.
- Excellent verbal and written communication skills, strong organization, and attention to detail, clarity, and accuracy.
- Forward-looking approach that identifies opportunities and proposes solutions.
Nice To Haves
- Experience with Python.
- R package development experience.
Responsibilities
- Lead programming activities as the Program Lead Programmer for an assigned compound and oversee related activities to ensure quality and timeliness.
- Act as Study Lead Programmer for one or more studies within the assigned compound.
- Set the overall programming strategy, tasks, priorities, and resources for the assigned compound.
- Provide program-level programming leadership and support to clinical development teams.
- Provide hands-on programming support for assigned studies and exploratory analyses, including responses to ad-hoc requests from regulatory agencies.
- Ensure deliverable quality 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 on programming conventions, standards, practices, and specifications to ensure integrated computing solutions.
- Review and/or author SOPs and Work Instructions related to statistical programming practices.
- Contribute to the creation, maintenance, and validation of internal standards for programming tools, outputs, and macros.
- Oversee contractors and coach junior team members.
- Collaborate with cross-functional teams in Biometrics, Clinical Operations, Regulatory, and Clinical Development, and with external vendors.
Benefits
- Comprehensive medical, dental, and vision coverage, mental health support, annual wellbeing reimbursement, and access to an Employee Assistance Program.
- 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 a competitive company match, annual equity awards, participation in the Employee Stock Purchase Plan, and company-paid life and disability insurance.
- Company Learning Institute with access to LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities.
- Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
