Biostats SME

Job Title: Clinical Standard SDTM

Job Location: Pan India (Preferrable: Delhi or Mumbai)

Exp Range: 4 - 18 Years

Job Description:

Roles and Responsibility:

• 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
• Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.

Description:

• At least 10-15 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.
• Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage