Principal Biostatistician – Remote (India) | Syneos Health
Location: India (Remote)
Job ID: 25102988
Updated: November 16, 2025
Position: Principal Biostatistician
Experience Required: 10+ years in Biostatistics with proven leadership in clinical trial statistics
About the Role
Syneos Health is hiring an experienced Principal Biostatistician to provide strategic statistical leadership across global clinical development programs. This role is fully remote in India and is responsible for advanced statistical design, complex data analysis, and oversight of biostatistical activities to support high-quality clinical research outcomes.
As a Principal Biostatistician, you will act as a key scientific contributor, collaborate with cross-functional teams, ensure statistical integrity, and influence decision-making across multiple therapeutic areas.
Key Responsibilities
Lead statistical strategy, planning, and execution across assigned clinical studies.
Develop statistical analysis plans, study designs, and sample size estimations.
Provide expert review of protocols, clinical study reports, and regulatory submissions.
Oversee statistical programming activities and validate complex datasets and outputs.
Ensure compliance with ICH-GCP, regulatory guidelines, and internal quality standards.
Guide biostatistics team members and act as a mentor for junior statisticians.
Collaborate with global project teams and external stakeholders to support study objectives.
Represent biostatistics in sponsor meetings, cross-functional discussions, and audits.
Ensure accuracy, consistency, and scientific validity of all delivered statistical outputs.
Contribute to process improvement, innovation, and best-practice implementation across biostatistics operations.
Required Qualifications & Experience
Education:
Master’s or Ph.D. in Biostatistics, Statistics, Mathematics, or related quantitative discipline.
Experience:
Minimum 10 years of relevant experience in biostatistics within the pharmaceutical, CRO, or clinical research industry.
Demonstrated leadership in statistical strategy for Phase I–IV clinical trials.
Technical Skills:
Strong proficiency in SAS and other statistical programming tools.
In-depth knowledge of clinical trial methodology and regulatory requirements (FDA, EMA, ICH, GCP).
Experience in authoring statistical documentation and regulatory submissions.
Core Competencies:
Excellent analytical, problem-solving, and communication skills.
Ability to manage multiple studies and deliver high-quality statistical outputs under timelines.
Strong cross-functional collaboration and team leadership capabilities.
Why Join Syneos Health?
Syneos Health is a globally recognized integrated biopharmaceutical solutions provider, with:
A workforce of over 29,000 employees across 110 countries.
Collaboration on 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the last five years.
Over 200 clinical studies supported at 73,000 global sites involving 675,000+ trial participants.
The organization offers:
Career development and professional growth programs
Supportive line management and technical training
Recognition initiatives and competitive benefits
A culture built around authenticity, inclusivity, and collaboration
Additional Information
Responsibilities outlined above are not exhaustive. Syneos Health may assign additional duties based on business needs. Equivalent skills or qualifications may be considered where applicable. The company remains committed to equal employment opportunities, reasonable accommodations, and global compliance standards.
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Siliguri |Illinois :
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