Biostatistician (East Coast Region)
- Biostatistics lead will lead solution definition for multiple clinical data analytics initiatives. 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
- Visualization tool (Spotfire, Qlikview, Jreview) will be a plus
- Knowledge of machine learning will be a big plus.
LSAC provides customers with the ability to leverage advances in technology, AI, and precision medicine to connect, contextualize, and analytically converse with all their drug development data assets. It accelerates time to market and positively impacts patient lives. The combination of Saama’s AI research, advanced technical & analytics capabilities, domain expertise across the drug development life cycle, and successful product co-development approach has made Saama a trusted partner and thought leader in the life sciences industry. Saama is committed to finding the best people because the innovations and discoveries that enabled together leads to better technologies, better treatments, and a better future
This job operates in home office
This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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