Associate Director, EDC Programming

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Consistently Ranked Science's Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2025, we became Great Place to Work-certified in the U.S. for the fifth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview

The Associate Director, EDC Programming will lead and oversee EDC programming, and database build for in-house clinical trials. This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and efficiency throughout the study lifecycle. The AD, EDC Programming will perform optimized EDC builds using established standards and efficient processes in the implementation and integration of patient data systems. The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.

Responsibilities

EDC System Design & Development:

• Lead the setup, development, and validation of EDC systems, including configuration settings, integration with other applications, and subsequent updates
• Create and maintain study databases, including eCRF design, edit checks, and custom functions in a timely manner with high quality
• Collaborate with cross-functional teams to ensure study requirements are adequately defined and help translate them into functional EDC specifications
• Collaborate with Medidata support and internal teams to troubleshoot and optimize platform performance

Medidata Rave Expertise:

• Serve as the subject matter expert (SME) for Medidata Rave, providing technical guidance and support to the team
• Review software upgrades and database releases for impact to configurations
• Provide support to DMs in creation of data listings using RAVE tools (e.g., Business Objects, other) and non-RAVE tools/applications (e.g., JReview, other)
• Facilitate/ support troubleshooting and resolution of technical issues related to Medidata Rave

Programming & Integration:

• Partner with internal data teams to support automation, reporting, and data exchange solutions
• Ensure all programming solutions comply with GCP, 21 CFR Part 11, and CDISC ODM Standards

Data Quality & Compliance:

• Ensure EDC systems comply with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and company SOPs
• Perform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracy
• Implement and monitor data quality checks to identify and resolve discrepancies
• Collaborate with partners (e.g., DSQA, CSV, CQA, other) to maintain compliance with EDC systems and associated applications
• Support audits and inspections by providing technical expertise and system documentation
• Ensure data integrity, system reliability, and regulatory compliance across all phases of clinical development

Team Leadership & Collaboration:

• Mentor and guide junior EDC programmers, fostering innovation, accountability, and continuous learning
• Collaborate with external vendors and CROs to ensure seamless integration of EDC systems
• Provide training and support to end-users on Medidata Rave, other EDC tools, and emerging technologies

Process Improvement:

• Identify opportunities to streamline EDC programming processes and improve efficiency
• Stay updated on industry trends and advancements in EDC technologies, particularly Medidata Rave
• Contribute to the development and implementation of best practices for EDC programming
• Develop and contribute on SOP creation

Position Requirements (Required and/or Preferred Skills, Experience, and Education):

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field. Advanced degree preferred
• Minimum of 7+ years of experience in EDC programming, configuration, and management of EDC systems, with at least 5 years of hands-on experience with Medidata Rave. Proven track record of leading EDC system design and implementation for clinical trials
• Advanced proficiency in the broader Medidata Clinical Cloud suite (e.g., Rave EDC, Rave Coder, Lab Administration, RTSM, eCOA, TSDV, RSG, and Designer) would be strongly desirable
• In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and clinical development processes
• Advanced proficiency in custom function programming, using C# is desirable
• Preferred proficiency in Python, C#, and JSON to support custom database integration programming, automation, development of custom tools, and data exchange solutions that enhance clinical trial efficiency
• Solid understanding of CDISC standards (CDASH, SDTM) and regulatory requirements for clinical data
• Experience with programming languages such as SQL, SAS, or Python is a plus
• Problem-solving skills, attention to detail, and the ability to work in a fast-paced, collaborative environment!
• Strong communication and interpersonal skills, with the ability to collaborate effectively across teams!
• Preferred experience in gene therapy and familiarity with biometrics technology software tools

Salary Range

$147,000 - $206,333 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

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 [email protected] 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.