Associate Director, Clinical Data Programmer

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

The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.

Responsibilities

• Serve as the inter-department subject matter expert for EDC platforms (Medidata RAVE) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making
• Contribute to development process and ensure compliance from a CDM / EDC and data programming perspective including SOPs, standardization of operational and technical methodologies
• Provide technical and functional oversight of the day-to-day use of CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, and quality control procedures, timelines, and documentation
• Participate in the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools
• Leads the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight.
• Supports leading data management activities (i.e. DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases.
• Performs UAT of systems and ensures appropriate plans and documentation are in place.
• Leads the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review.
• Manages external vendor compliance and quality checks.
• Supports Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges.
• Ensures databases adherences to SOPs, 21CRF Part 11, ICH-GCP and CDISC Standards (CDASH/SDTM)
• Acts as a subject matter expert in leading technical initiatives and data management

Required Qualifications

• Bachelor’s degree or higher in Life Science or related discipline
• 8+ years of experience in clinical data management
• Extensive experience with clinical data systems (particularly Medidata Rave) and languages like SAS, R or Python
• Proven experience in clinical trial programming and database management
• Knowledge of Clinical Data Standards such as CDISC CDASH, and SDTM
• Provide strong support to Data Management
• Experience creating advanced interactive data visualizations from raw data using multi-languages and applications such as Using SAS, R, Python, RShiny, Power BI, Tableau, Spotfire etc.
• 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.

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, which may include travel by air, driving or public transportation.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote locatio

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

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