Associate Director, Statistical Programming

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.

Required Qualifications

• 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.

Work Location and Conditions

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range
$188,000 - $211,000 USD

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Amylyx Pharmaceuticals is an Equal Opportunity Employer 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 conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. 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. Accommodations are available for candidates who require them in our selection process.

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