Job Responsibilities
- Provides leadership and guidance across Biometrics initiatives within the India region,facilitatesstrategic discussions, and contributes to global planning to enableoptimalend-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 inclose collaboration with global heads of Biostatistics, Programming, and Data Scienceto 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.
- Overseesand 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, ensuringtimelyupdates 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 enhancevaluedelivery 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 generatingnew ideasand 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.Ensuresregular 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, ensuringappropriate resourcingand talent development in alignment with both regional and global business goals.
QUALIFICATION REQUIREMENTS
- Education & Experience:
- Advanced degree (Master sor Ph.D.) in Biostatistics, Statistics, Data Science, Computer Science, Life Sciences, or a related disciplinerequired.
- Minimum of12 15 years of progressive experiencein clinical research and biometrics functions (Biostatistics, Programming, and/or Data Science), with at least5 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:
- Knowledgeof clinical trial processes, statistical methodologies, CDISC standards (SDTM,ADaM), and regulatory submission requirements (e.g., FDA, EMA).
- Demonstratedexpertisein 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.
