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Associate Director, Clinical Data Programmer

On-site Full-time $183K/yr - $206K/yr

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Experience Level

Senior Level Manager

Qualifications

ResponsibilitiesDirect the design, development, and validation of study-specific clinical data capture systems, ensuring data integrity, CDISC compliance, and oversight of CRO activities. Lead data management activities including the creation of Data Management Plans (DMP), Case Report Forms (CRF), and edit checks, as well as managing database setup, conduct, and closeout phases. Conduct User Acceptance Testing (UAT) of systems and ensure thorough documentation and planning. Oversee the development of SAS macros, data listings, summary tables, and visualizations for periodic and ad hoc data reviews. Manage compliance and quality checks for external vendors. Support Clinical Operations, Biostatistics, and Data Management with data insights and solutions to technical challenges. Ensure databases comply with SOPs, 21 CFR Part 11, ICH-GCP, and CDISC standards (CDASH/SDTM). Serve as a subject matter expert for leading technical initiatives and data management. Required QualificationsBachelor’s degree or higher in a relevant field. Proven experience in clinical data programming and management. Strong understanding of regulatory requirements and industry standards.

About the job

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases that have significant unmet needs. While others may see obstacles, we actively pursue opportunities with urgency, rigorous scientific methods, and a steadfast commitment to the communities we serve. As a clinical-stage company, we are currently targeting conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is driven by our talented team, united by core values that include being audacious, curious, authentic, engaged, and accountable, fostering a culture of compassion. At Amylyx, we have assembled a highly experienced group dedicated to action, as the communities we serve cannot afford to wait. If you share our passion and are committed to addressing some of the most challenging problems in medicine, we invite you to explore this opportunity and apply.

The Opportunity

The Clinical Data Management team at Amylyx Pharmaceuticals is in search of an Associate Director, Clinical Data Programmer. In this role, you will collaborate across functions to deliver hands-on data management support, programming expertise, and technical leadership. You will be responsible for developing, maintaining, and validating clinical databases, as well as executing computer programs to access, visualize, and report clinical trial data, adhering to clinical plans, ICH guidelines, and regulatory standards. As the Associate Director of Clinical Data Programming, proficiency in programming languages is essential for creating both textual and graphical representations that facilitate data cleaning and review.

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is a pioneering clinical-stage company dedicated to transforming healthcare for patients with severe unmet medical needs. Our focused efforts on diseases like post-bariatric hypoglycemia, Wolfram syndrome, and ALS reflect our commitment to innovative and urgent medical solutions.

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