Job
Description
As a Biostats Subject Matter Expert (SME) with over 7 years of experience, you will play a crucial role in the Clinical Standards and Digital Data Flow domain. Your expertise in areas such as Metadata Repository, Biometrics, EDC, non-CRF, TFLs, SDR, and USDM will be instrumental in addressing the needs, challenges, and innovative trends on a global scale. Your outstanding communication skills will be key in translating complex technology into clear and easy-to-understand language for cross-pharma senior management network. You will be part of the strategic group at TCS Life Sciences, collaborating closely with TCS ADD Product, Business Development, Marketing teams, and global pharma leaders. Your responsibilities will include driving strategic positioning, roadmap development, and solution creation for Clinical Standards and Digital Data Flow globally. Additionally, you will co-lead thought leadership initiatives, marketing activities, advisory boards, and partnerships in these domains. Key Responsibilities: - Contribute to building products and solutions in Digital Data Flow by providing subject matter expertise and industry trend knowledge - Assist in developing differentiated product offerings to enhance sales and attract more customers - Co-lead the global strategic positioning and roadmap for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics, Data Management, TFLs, SDR, and USDM - Collaborate on the design and development of these solutions from a business perspective - Drive thought leadership initiatives, external visibility through articles, webinars, and conferences, and represent TCS at industry consortia - Support the business development team with customer presentations, RFI/RFP requests, and go-to-market strategy Qualifications Required: - Master's degree in sciences (e.g., biology, biomedical, pharmacy, statistics) or equivalent expertise; PhD is advantageous - Minimum 6 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, preferably in top-15 pharma companies or CROs - Extensive hands-on experience with data collection standards, biostatistical programming, STDM, ADaM, TFL, and regulatory submission packages, including automation tools and strategies - Experience in applying AI in standardization, SDTM, ADaM, and TFL generation - Proficiency in setting strategies for EDC build from study protocol, SDR Model, USDM, and innovative automation testing and validation - Proven track record of building trust with customers, employees, and stakeholders, along with a broad cross-pharma senior management network - Outstanding communication skills to simplify complex technology and drive results in ambiguous situations You will be a key player in shaping the future of Clinical Standards and Digital Data Flow, contributing to innovative solutions and driving business success through your expertise and strategic leadership. As a Biostats Subject Matter Expert (SME) with over 7 years of experience, you will play a crucial role in the Clinical Standards and Digital Data Flow domain. Your expertise in areas such as Metadata Repository, Biometrics, EDC, non-CRF, TFLs, SDR, and USDM will be instrumental in addressing the needs, challenges, and innovative trends on a global scale. Your outstanding communication skills will be key in translating complex technology into clear and easy-to-understand language for cross-pharma senior management network. You will be part of the strategic group at TCS Life Sciences, collaborating closely with TCS ADD Product, Business Development, Marketing teams, and global pharma leaders. Your responsibilities will include driving strategic positioning, roadmap development, and solution creation for Clinical Standards and Digital Data Flow globally. Additionally, you will co-lead thought leadership initiatives, marketing activities, advisory boards, and partnerships in these domains. Key Responsibilities: - Contribute to building products and solutions in Digital Data Flow by providing subject matter expertise and industry trend knowledge - Assist in developing differentiated product offerings to enhance sales and attract more customers - Co-lead the global strategic positioning and roadmap for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics, Data Management, TFLs, SDR, and USDM - Collaborate on the design and development of these solutions from a business perspective - Drive thought leadership initiatives, external visibility through articles, webinars, and conferences, and represent TCS at industry consortia - Support the business development team with customer presentations, RFI/RFP requests, and go-to-market strategy Qualifications Required: - Master's degree in sciences (e.g., biology, biomedical, pharmacy, statistics) or equivalent expertise; PhD is advantageous - Minimum 6 years of global drug development experience in Digital Data Flow, metadat
