Remote Lead, Statistical Programming

Summary

The job is for a Statistical Programmer at Amylyx Pharmaceuticals, responsible for coding SAS programs for assigned clinical projects, designing and delivering CDISC and regulatory compliant SDTM and ADaM datasets, and performing quality control checks on SAS code. The role requires an MS in Statistics, Computer Science or a related field with at least 6 years of SAS programming experience in the pharmaceutical or biotech industry.

Requirements

• MS in Statistics, Computer Science, or a related field with at least 6 years of SAS programming experience in the pharmaceutical or biotech industry. (BS in Statistics, Computer Science ore related field with at least 8 years’ experience in pharma or biotech also considered)
• Proficient in SAS programming
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
• Working knowledge of R strongly preferred
• Experience in leading statistical programming to early and late phase clinical trials, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format and regulatory submissions (NDA, MAA)
• Experience with FDA and ICH regulations and guidelines
• Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
• Excellent written and verbal communication skills and organizational and documentation skills
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc

Responsibilities

• Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)
• Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets including datasets specifications for datasets programming
• Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TFLs
• Create and review eCTD documents to support regulatory submission package
• Provide programming support for building integrated summary of safety/efficacy datasets and analysis
• Provide programming support for ad hoc analyses and data listing review