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.
Travel Requirements
This role requires occasional travel (approximately 15%)
#LI-Remote
#LI-DM1
Pay Range
$164,000.00-213,000.00 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.
Current Insmed Employees: Please apply via the Jobs Hub in Workday.
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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to recruitmentfraud@insmed.com.
