Description

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 four 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:
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.

What You'll Do:

• 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' 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

Who You Are:

• Bachelor's 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

#LI-Remote

Pay Range:
$147,000.00-206,333.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our 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 a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.