Director, Biometrics

Job Responsibilities

• Provides leadership and guidance across Biometrics initiatives within the India region, facilitates strategic discussions, and contributes to global planning to enable optimal end-to-end delivery of clinical biometrics services.
• Oversees and supports the India Biometrics team, ensuring their performance aligns with global functional expectations, quality standards, and strategic direction.
• Works in close collaboration with global heads of Biostatistics, Programming, and Data Science to translate strategic global initiatives into regional operational execution, with a strong focus on delivery quality, process harmonization, and compliance.
• Leads the development, review, and continuous refinement of Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated forms/templates that align with global standards and regulatory expectations within clinical research.
• Provides strategic leadership for the development, implementation, and continuous enhancement of robust training programs across the India Biometrics team including credentialing, onboarding, and upskilling initiatives.
• Oversees and ensures compliance with training certification processes via the company s Learning Management System (LMS), including guidance to the Certification Management Committee and functional councils.
• Leads root cause analysis and improvement efforts in response to Quality Issues (QIs), audit findings, and cross-functional compliance concerns, ensuring timely updates to processes and procedures based on feedback and trends.
• Engages and influences both internal and external stakeholders to drive strategy and foster a culture of operational excellence and cross-functional alignment, contributing to continuous improvement initiatives globally and regionally.
• Directs the identification, scoping, and execution of process improvements across Biometrics using proven methodologies such as Lean Six Sigma to enhance value delivery and efficiency.
• Drives regional communication and execution of Biometrics Optimization plans related to procedural documentation, training development, and quality improvement.
• Champions a culture of innovation by encouraging and supporting the India Biometrics team in generating new ideas and solutions to improve performance and client satisfaction.
• Supports and contributes to the achievement of Biometrics BU financial targets through strategic resourcing, team efficiency, and operational excellence.
• Maintains up-to-date knowledge of clinical research industry standards and trends to ensure continuous alignment with global best practices.
• Mentors and supports regional Biometrics personnel in executing process improvement initiatives, providing hands-on coaching and support to foster professional development.
• Holds full line management responsibilities for the regional Biometrics leadership team, including performance management, succession planning, and professional development. Ensures regular team meetings, one-on-one check-ins, and a culture of continuous feedback and engagement.
• Leads workforce planning and recruitment strategies for India Biometrics operations, ensuring appropriate resourcing and talent development in alignment with both regional and global business goals.

QUALIFICATION REQUIREMENTS

• Education & Experience:
• Advanced degree ( Master s or Ph.D.) in Biostatistics, Statistics, Data Science, Computer Science, Life Sciences, or a related discipline required .
• Minimum of 12 15 years of progressive experience in clinical research and biometrics functions (Biostatistics, Programming, and/or Data Science), with at least 5 years in a senior leadership or regional/global management role .
• Experience working in a global CRO, pharmaceutical, or biotech environment with exposure to multinational team leadership and cross-cultural collaboration.
• Technical Expertise:
• Knowledge of clinical trial processes, statistical methodologies, CDISC standards (SDTM, ADaM ), and regulatory submission requirements (e.g., FDA, EMA).
• Demonstrated expertise in implementing and overseeing data management, statistical programming, and biostatistical analysis strategies.
• Familiarity with statistical software tools such as SAS, R, or Python, and enterprise-level clinical systems and platforms (e.g., Medidata, Oracle Clinical, Veeva, etc.).
• Leadership & Collaboration:
• Proven ability to lead, inspire, and manage large, cross-functional biometrics teams, preferably across multiple geographies.
• Strong interpersonal and communication skills with the ability to influence global stakeholders and collaborate effectively with functional heads.
• Experience translating global strategy into regional operational excellence and driving process improvements at scale.