Associate Director, Clinical Programming
Location: Bridgewater
Posted on: June 23, 2025
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Job Description:
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 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.
Keywords: , West Orange , Associate Director, Clinical Programming, Science, Research & Development , Bridgewater, New Jersey