Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is a clinical-stage company focused on developing treatments for diseases with high unmet needs. The Associate Director, Clinical Data Programmer will provide hands-on clinical data management and programming support, technical leadership, and oversight for clinical database development, validation, data review, and reporting in compliance with clinical plans, ICH guidelines, and regulatory requirements.
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
Skills
- 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
- 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
Benefits
- Remote work opportunities within the United States
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