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Biostatical Submissions

Date Posted: Sep 30, 2026
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Job Detail

  • location_on
    Location Mumbai, Maharashtra, India
  • desktop_windows
    Job Type: Full Time/Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
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    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Nov 14, 2026
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Job Description

TCS is Hiring for

Role : Clinical – Biostatical Submissions

Roles & Responsibilities

  • 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. 

Requirement

  • 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. 

Thanks & Regards

Babeeta Shahi 

About the role
  • Role: Assistant
  • Qualifications: BACHELOR OF LIBRARY SCIENCE, MASTER OF PHARMACY, MASTER OF SCIENCE
  • Experience: 10 - 15 Years
  • Skills: Statistics
  • Function: BUSINESS PROCESS SERVICES
  • Location: Mumbai
  • Apply by: 2026-09-30

Source: Tata Consultancy Services careers — Read the original posting and apply

This role is listed by the employer on its own careers site. Kaam Ki Khoj does not process applications for it.

Company Overview

Tata Consultancy Services
Tata Consultancy Services · Mumbai, Maharashtra, India
400 open roles

Tata Consultancy Services is an employer in the IT/Computers - Software, Software Services sector with operations in India. This is a directory listing maintained by Kaam Ki Khoj so that candidates can find the organisation; it is not an official com... Read More

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