Biostatical Submissions

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