Associate Director, Clinical 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 2024, we became Great Place to Work-certified in the U.S. for the fourth 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, Clinical Programming provides technical leadership and ensures adequate clinical 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 clinical 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 clinical programming leadership and support to clinical development teams 
• Provides hands-on programming support to clinical programming activities, both internally and in response to regulatory agencies' requests for information as needed
• 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 clinical 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'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 data visualization software packages (e.g., JReview)
• Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval
• Significant experience in clinical programming with an understanding of data management
• 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

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/Affirmative Action employer. 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.