Lead, Statistical Programming

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we're bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer's disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.
Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• AMX0035 is currently under review with the European Medicines Agency
• 350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

POSITION SUMMARY
Reporting into the Head of Statistical Programming, 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.
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.

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.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.