About the role
TCS hiring for Clinical Standards & Digital Data Flow Leader / Clinical Biostatistical Submissions Leader
Exp- 10 - 15 Years
Location- PAN INDIA
We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management (EDC, non-CRF), TFLs, SDR, USDM within-depth insights in needs, challenges and innovative trends in these domains at a global level.Qualifications and education
·Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
Experience-
Global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA.
- Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation.
- Experience in applying AI in standardization, SDTM, ADaM and TFL generation.
- Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM
- Experience in innovative ways to automate testing and validation
Qualifications: MASTER OF ENGINEERING, MASTER OF PHARMACY, MASTER OF SCIENCE, MASTER OF STATISTICS, MASTER OF TECHNOLOGY