12.0 - 15.0 years

40 - 45 Lacs

hyderabad

Work from Office

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. Other Competencies: Strong business acumen with experience managing departmental budgets, headcount planning, and contributing to P&L goals. Demonstrated commitment to quality, compliance, and continuous improvement. Excellent organizational, problem-solving, and decision-making skills in a dynamic, matrixed environment.

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