Sr Manager, 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 Sr Manager, Clinical Programming will provide clinical programming support to multiple clinical studies and submissions. As a senior member of the Programming function, the Sr Manager, Clinical Programming will be working interactively with functional colleagues from Biostatistics, Data Management, Clinical Trial Operations, and Clinical Development, as well as external vendors.

Responsibilities

Responsibilities (Essential Role Responsibilities):•    Leads the clinical programming activities and related oversight activities ensuring quality and timeliness across multiple studies•    Sets tasks, prioritization, and resources for clinical programming on assigned studies•    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•    Motivates and mentors Managers and Sr Programmers to complete assigned deliverables on time and with high quality•    Leads non project initiatives and utilizes resources to meet corporate objectives•    Provides review and/or authors SOPs and/or Work Instructions related to clinical programming practices•    Ensures creation of specifications for data transformation in accordance with SDTM IG and SAP•    Creates CDISC compliant deliverables - SDTM datasets and annotated eCRFs (aCRF) or ensures the quality of these deliverables produced by a vendor•    Works with clinical development teams to ensure the creation of medical monitoring reports, data cleaning reports, data reconciliation reports, and data visualizations as needed•    Ensures professional development to enhance knowledge, skills, communication, scientific methodology, operational efficiency, and compliance with policies, regulations, and corporate standards and processes  Position Requirements (Required and/or Preferred Skills, Experience and Education):•    Requires a Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Engineering or related field of study•    Master’s degree or higher in Statistics, Computer Science, Mathematics, Engineering or related field of study is a plus•    Minimum 6-7 years of work experience in a pharmaceutical/biotech (preferred) or related industry•    Solid programming background and advanced SAS, R, or Python programming skills required. •    Significant knowledge of data visualization tools (e.g., JReview) is required•    Strong experience in clinical programming with an understanding of data management•    Prior submission experience is a plus•    Prior experience in line management (direct reports) is a plus•    CDISC experience in SDTM standards is required•    Must have excellent communication skills (verbal and written)!•    Highly organized with a strong attention to detail, clarity, accuracy, and conciseness•    Individuals must demonstrate the ability to inte