Associate Director, Statistical Programming

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.

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

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.