Job Title
Biostatistics Submissions – Clinical Standards & Digital Data Flow Leader
Company: Tata Consultancy Services (TCS)
Experience Required: 8–15 Years
Location Options: Mumbai / Pune / Bangalore / Delhi
Job Function: Business Process Services
Job Level: Lead
Job Overview
This role focuses on Clinical Biostatistics Submissions, Digital Data Flow, and Clinical Data Standards leadership within global drug development.
You will act as a strategic leader and subject matter expert (SME) in areas such as:
Clinical data standards (SDTM, ADaM, etc.)
Digital data flow and metadata systems
Biometrics and regulatory submissions
Clinical data management systems (EDC, non-CRF systems)
The role is highly strategic and involves working closely with global pharma leaders, product teams, and business stakeholders.
Business Context
TCS Life Sciences provides services across:
Clinical research
Regulatory operations
Pharmacovigilance
Digital and AI-driven healthcare solutions
You will work within the ADD (Advanced Drug Development) platform, contributing to modern clinical development solutions powered by digital and AI technologies.
Key Responsibilities
1. Strategic Leadership & Solution Development
Define and contribute to clinical standards and digital data flow strategy
Lead roadmap development for:
Clinical data standards
Metadata repositories
Biometrics solutions
2. Clinical Data Standards & Biometrics Expertise
Provide SME guidance on:
SDTM and ADaM datasets
TFL (Tables, Listings, Figures)
SDR (Statistical Data Review)
USDM (Unified Study Data Model)
Regulatory submission packages
Ensure alignment with global industry standards
3. Product & Platform Development
Work with product teams to design and improve digital solutions
Contribute to:
Product innovation
Solution architecture
Industry-aligned data systems
Support expansion of product adoption across global clients
4. Business Development & Client Engagement
Support:
Customer presentations
RFI/RFP responses
Go-to-market strategies
Engage with senior pharma stakeholders globally
Build strategic client relationships and partnerships
5. Thought Leadership & Industry Representation
Contribute to:
Industry articles
Webinars
Conferences
Cross-industry forums
Participate in global consortia (e.g., CDISC)
Establish leadership presence in clinical data standards space
6. Advisory & Strategic Consulting
Act as advisor for pharma clients on:
Digital transformation in clinical trials
Data flow optimization
Biometrics and submission strategies
Support innovation in clinical data ecosystems
Required Qualifications
Master’s degree in:
Life Sciences (Biology, Biomedical, Pharmacy)
Statistics
Or related scientific field
PhD preferred (advantage)
Experience Required
Minimum 8+ years (up to 15 years preferred) in:
Global drug development
Clinical data standards
Digital data flow
Biometrics
Data management systems (EDC, non-CRF)
Experience preferably in:
Top pharmaceutical companies
Leading CROs
Key Skills Required
Strong expertise in:
Clinical data standards (SDTM, ADaM, etc.)
Clinical biometrics
Digital clinical data systems
EDC and clinical data management tools
Excellent communication skills
Ability to translate technical concepts into business language
Strong stakeholder management and networking ability
Strategic thinking and leadership capability
Desired Skills
Statistics background preferred
Knowledge of regulatory submission processes
Experience with global pharma collaboration
Exposure to CDISC and industry standards organizations
Job Requirements Summary
Strong leadership in clinical data & biometrics domain
Ability to drive global strategy and innovation
Client-facing senior consulting experience
Deep understanding of clinical data ecosystem
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