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Job Information
Insmed Inc. Associate Director, Medical Affairs Programming in Bridgewater, New Jersey
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, Medical Affairs Programming provides technical leadership and ensures adequate programming support for assigned projects supporting Medical Affairs. Assists the Head of Programming to ensure successful implementation of programming strategies and efficient execution of analyses for assigned Medical Affairs projects, including ad hoc requests and publications. Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Medical Affairs, as well as with external vendors. Oversees contractors and coaches junior team members. Responsibilities * Leads the Medical Affairs 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 Medical Affairs teams * Provides hands-on programming support to programming activities supporting Medical Affairs, both internally and in response to requests for information about publications 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 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 statistical software packages * Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval * Significant experience providing programming support for Medical Affairs activities * 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 * ExcelleTo view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjQxMDMxLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t