Associate Director, Programming

Role Summary

The Associate Director, Programming provides technical leadership and ensures adequate programming support for assigned projects. Assists the Head of Programming to ensure successful implementation of Programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development, as well as with external vendors. Oversees contractors and coaches junior team members.

Responsibilities

• Leads the programming activities across a compound (or multiple compounds) and related oversight activities ensuring quality and timeliness
• Sets tasks, prioritization, and resources within assigned compound(s)
• Provides program-level programming leadership and support to clinical development teams
• Provides hands-on programming support to exploratory analyses, both internally and in response to regulatory agencies‚Äô ad-hoc requests
• Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and Work Instructions
• Leads process improvement initiatives
• Provides technical guidance to Insmed programmers, contractors, and vendors around project conventions, standards, practices, and specifications to ensure integrated computing solutions
• Provides review and/or authors SOPs and/or Work Instructions related to statistical programming practices
• Contributes to the creation, maintenance, and validation of internal standards for programming tools, outputs, and macros
• Assists the Head of Programming in assessing the programming environment to ensure programming and analysis efficiency, identifying ways to enhance the system where needed and acts as the subject matter expert on the system

Qualifications

• Bachelor‚Äôs degree in statistics, biostatistics, mathematics, computer science, or equivalent required, advanced degree preferred
• Minimum of 8 years of clinical/statistical programming experience in a biotech, pharmaceutical, or CRO setting required
• Extensive knowledge of SAS software (i.e., Base, Stat, Graph components) and general computing techniques in addition to knowledge of R or other statistical software packages
• Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval
• Significant 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 projects in a fast-paced environment
• Ability to problem-solve
• Strong project management skills
• Excellent verbal and written communication skills; able to communicate proactively and effectively

Skills

• Programming leadership
• Regulatory submission support
• SDTM/ADaM/CDISC standards
• Analytical thinking and problem-solving
• Cross-functional collaboration

Education

• Bachelor‚Äôs degree in statistics, biostatistics, mathematics, computer science, or equivalent; advanced degree preferred