Associate Director, Statistical Programming

Amylyx Pharmaceuticals•Cambridge, MA

2d•$188,000 - $211,000•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Reporting into the Statistical Programming function, you will be responsible for providing hands-on programming support and technical guidance on clinical trials and regulatory submissions. In this role you will lead design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. You will participate in departmental and cross-functional technology development and process improvement initiatives.

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 or 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.

Nice To Haves

Working knowledge of R strongly preferred.

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.