Analytical Services
Multiple,
United States
Description
- Bachelors or Master’s degree in relevant fields.
- 8+ years of relevant professional experience in a leadership position creating SDTM & ADaM deliverables.
- Understands how clinical studies are run and managed and submitted to regulatory agencies across the globe and has worked as a TA or compound lead for at least 5+ studies over 2+ organizations over the last 5 years
- Has significantly improved efficiency in Clinical Trials by digitizing processes, consolidating processes, or introducing extreme automation for manual processes
- Will be responsible for defining next generation solution that helps in Clinical trial effectiveness and submission pathway.
- Strong experience with developing submission outputs – e.g. SDTM datasets, ADaM datasets, define.XML, TLG (table listing and graphs)
- Hands on experience developing programs to create SDTM & ADaM outputs (multiple studies)
- Ability to provide specifications for automating creation of SDTM & ADaM outputs
- Deep expertise with EDC & other clinical data sources (e.g. Lab)
- Deep experience in all the Biostats process (patient data analytics, cross trial analytics)
- Ability to create visualizations on SDTM & ADaM data
- Experience in performing the business process SDTM & ADaM conversion
- Should be leading a team performing the Biostats activities (preferably from Pharma or CRO)
- Apart from SAS, Programming experience in another language e.g. R,python) will be a plus