Associate Director, Statistical Programming

Responsibilities

• Design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
• Produce and deliver CDISC and regulatory compliant SDTM and ADaM standard datasets
• Develop and execute statistical analysis and reporting deliverables including tables, figures and listings (TFLs)
• Perform quality control checks and validation of SAS code and output
• Create and review eCTD documents to support regulatory submission packages
• Provide programming support for integrated summary of safety/efficacy datasets and ad hoc analyses

Requirements

• MS in Statistics, Computer Science, or related field with 6+ years of SAS programming experience in pharma/biotech
• BS in Statistics, Computer Science, or related field with 8+ years of experience
• Proficient in SAS programming
• In-depth knowledge of CDISC standards (SDTM and ADaM) and FDA electronic data submission requirements
• Experience leading statistical programming for early and late phase clinical trials
• Experience with FDA and ICH regulations and guidelines
• Strong communication and organizational skills

Preferred Qualifications

• Working knowledge of R

About the Company

Amylyx is a clinical-stage company focused on treating diseases with high unmet needs, including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).