Director of Contract Manufacturing Engineering at Thermo Fisher driving cost - out strategy across Asia. Building partnerships and improving operational performance in the manufacturing network.
About the role
- Director of Biometrics overseeing clinical programming and biostatistics at Syneos Health. Leading regional operations and collaboration with global teams to optimize biometrics services.
Responsibilities
- Provides leadership and guidance across Biometrics initiatives within the India region
- Oversees and supports the India Biometrics team
- Works in close collaboration with global heads of Biostatistics, Programming, and Data Science
- Leads the development, review, and continuous refinement of Standard Operating Procedures (SOPs)
- Provides strategic leadership for the development, implementation, and continuous enhancement of robust training programs
- Oversees and ensures compliance with training certification processes via the company’s Learning Management System (LMS)
- Leads root cause analysis and improvement efforts in response to Quality Issues (QIs), audit findings, and cross-functional compliance concerns
- Engages and influences both internal and external stakeholders
- Directs the identification, scoping, and execution of process improvements across Biometrics
- Drives regional communication and execution of Biometrics Optimization plans
- Champions a culture of innovation by encouraging and supporting the India Biometrics team
- Supports and contributes to the achievement of Biometrics BU financial targets
- Maintains up-to-date knowledge of clinical research industry standards and trends
- Mentors and supports regional Biometrics personnel
- Holds full line management responsibilities for the regional Biometrics leadership team
- Leads workforce planning and recruitment strategies for India Biometrics operations
Requirements
- 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 (Clinical Programming), 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.
- 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.).
- 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.
- 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.
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Job title
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