Biostats SME

Role : Biostats SME

Experience : 7 Plus Years

Location : Noida

Job Description : 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 communication skills

with ability to translate technology in a clear & easy-to-understand language and

cross-pharma senior management network

are fundamental to this role.

Department description

The Clinical -Standards and Digital Data Flow Leader is part of the strategic group of TCS Life Sciences and will work closely with TCS ADD Product, Business Development and Marketing teams as well as multiple pharma leaders at a global level.

You will be responsible for the strategic positioning, roadmap and solution development from a business perspective for Clinical – Standards and Digital Data Flow at a global level. You will drive and co-lead thought leaderships, marketing material, advisory boards and partnerships. You will support customer presentations, industry events and RFI / RFP requests of life science leaders in these domains.

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.