TCS is hiring for Biostatical Submissions
Job Location – Mumbai/Pune/Bangalore/Delhi
Experience Range – 8 to 15 Years
Qualifications and education
- Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
- At least 6 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs)
Job Description: Clinical – Biostatical Submissions
Then this function of Clinical – Standards and Digital Data Flow Leader at Life Sciences (LS) might an excellent opportunity. 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. Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role.
Department description & Function Positioning.
Life Sciences offers diverse services (e.g. clinical, IT, advisory) and novel state-of-art platform solutions (e.g. AI, IoT driven) to the life science industry. One of the platform solutions is ADD”, a modern & open drug development platform with a wide range of offers in the clinical, regulatory and safety domain.
The Clinical -Standards and Digital Data Flow Leader is part of the strategic group of Life Sciences and will work closely with ADD Product, Business Development and Marketing teams as well as multiple pharma leaders at a global level.
You will be responsible for the strategic positioning, roadmap and solution development from a business perspective for Clinical – Standards and Digital Data Flow at a global level. You will drive and co-lead thought leaderships, marketing material, advisory boards and partnerships. You will support customer presentations, industry events and RFI/RFP requests of life science leaders in these domains.
Main responsibilities and duties
- Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends.
- Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product.
- Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.)
- Co-leads the design & development for these solutions from a business view
- Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards and represents at consortia (e.g. CDISC)
- Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.
