Clinical – Biostatical Submissions

We are Hiring for Clinical – Biostatical Submissions (Domain SME)
Interested folks can share resume on below mail ID:
pallavi.chaughule@tcs.com
Experience: 10 to 15 years only
Location: Delhi/NCR only
JD:
Then this function of Clinical – Standards and Digital Data Flow Leader at Tata Consultancy Services (TCS) 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 with in-depth insights in needs, challenges and innovative trends in these domains at a global level. Outstanding communciation skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role.
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 TCS 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.
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)
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
Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners.
Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI)
Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language
Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.

Work arrangement
No