Principal Biostatistician Clinical Programming

The Principal Biostatistician - Clinical Programming will lead statistical strategy, analysis planning, clinical programming oversight, statistical review, submission support, and project-level biostatistics delivery at Syneos Health, Pune. This requires 5–10 years of experience in biostatistics, clinical programming, training, Agile workflows, and clinical trial data analysis.

Roles & Responsibilities

• Lead statistical planning and analysis strategy for assigned clinical studies.
• Provide input to protocol design, endpoints, sample size, and statistical methodology.
• Review and approve statistical analysis plans, TLF shells, datasets, and outputs.
• Oversee clinical programming deliverables and ensure statistical accuracy.
• Coordinate with statistical programmers, clinical teams, medical writing, data management, and sponsors.
• Interpret study results and support clinical study reports and regulatory submissions.
• Provide statistical guidance on study design, analysis assumptions, and data interpretation.
• Lead review of statistical outputs, quality checks, and submission packages.
• Support regulatory responses, client discussions, and inspection readiness.
• Mentor biostatisticians and programming team members.
• Participate in Agile project planning, risk management, and deliverable tracking.
• Maintain statistical documentation, decision logs, and analysis traceability.
• Improve statistical standards, templates, and best practices.
• Ensure high-quality, compliant, and scientifically robust biostatistics delivery.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through innovative clinical development, medical affairs, and commercial solutions. Headquartered in Morrisville, North Carolina, USA, the company partners with pharmaceutical, biotechnology, and medical device organizations to bring life-changing therapies to patients faster and more efficiently.

With a global workforce of more than 26,000 professionals across over 110 countries, Syneos Health combines deep scientific expertise, advanced technologies, and market insights to help customers navigate the complexities of drug development and commercialization. The organization has established itself as one of the world's leading contract research and biopharmaceutical services companies.

Our Vision

Accelerating the impact of life-changing therapies worldwide. Through collaboration, innovation, and scientific excellence, Syneos Health strives to improve patient outcomes and transform healthcare globally.

Our Purpose

Driven to Deliver

At Syneos Health, every team member is united by a common purpose—to contribute to innovations that have the potential to improve and save lives. The organization believes in creating real-world impact by helping customers bring new therapies to patients with greater speed and confidence.

Core Service Areas

Syneos Health offers comprehensive solutions across the biopharmaceutical value chain, including:

• Clinical Development Services
• Phase I-IV Clinical Trials
• Medical Affairs Solutions
• Regulatory and Scientific Consulting
• Commercialization and Market Access
• Real-World Evidence and Data Analytics
• Pharmacovigilance Services
• Sales and Marketing Solutions
• Communications and Consulting Services
• AI-Driven Clinical and Commercial Solutions

These integrated capabilities enable customers to accelerate development timelines and maximize the value of their therapies.

Therapeutic Expertise

Syneos Health possesses extensive expertise across multiple therapeutic areas, including:

• Oncology and Hematology
• Central Nervous System Disorders
• Cardiovascular Diseases
• Infectious Diseases
• Rare Diseases
• Immunology
• Respiratory Medicine
• Metabolic Disorders
• Vaccines and General Medicine

The company has supported the development or commercialization of a significant percentage of novel drugs approved by regulatory authorities in recent years.

Global Reach

Operating across six continents, Syneos Health supports customers worldwide through its broad network of professionals, physicians, scientists, and operational experts. The company's collaborative approach helps biopharmaceutical organizations navigate evolving market demands and deliver innovative treatments to patients faster.

Core Values

Syneos Health is guided by principles that emphasize:

• Customer Focus
• Integrity and Transparency
• Collaboration and Teamwork
• Innovation and Agility
• Scientific Excellence
• Diversity, Equity, and Inclusion
• Accountability and Quality

These values drive the organization's commitment to delivering exceptional results and fostering long-term partnerships.

Why Choose Syneos Health?

• Leading global biopharmaceutical solutions organization
• Presence in more than 110 countries
• 26,000+ employees worldwide
• Integrated clinical and commercial expertise
• Advanced AI-driven capabilities
• Deep therapeutic and scientific knowledge
• Strong commitment to innovation and patient outcomes
• Trusted partner for pharmaceutical and biotechnology companies

Our Commitment

At Syneos Health, we believe that every innovation has the power to change lives. Through scientific excellence, operational expertise, and collaborative partnerships, we are committed to accelerating the development and delivery of life-changing therapies that improve health and transform the future of medicine.