Amylyx Pharmaceuticals

Associate Director, Statistical Programming

Cambridge, MA · Director

Sponsorship not specified$188k-$211kDetected 12 days ago

StatisticsProcess ImprovementRecruitingClinical TrialsFDA RegulatoryPharmacovigilanceSASCommunicationBiostatistics

About the role

You will participate in departmental and cross-functional technology development and process improvement initiatives.

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.

In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
Experience with FDA and ICH regulations and guidelines.

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$188,000 - $211,000 USD
Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related condition

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.