Senior Biostatistician
Location:
Chennai, India (Hybrid/Remote options available)
Department:
Biostatistics
About the Company
A well-established, full-service CRO with over three decades of experience supporting statistical analyses and programming across all phases of drug development. The Biostatistics Division is recognized for its scientific integrity, quality deliverables, and timely execution.
Role Overview
The organization is seeking an experienced Senior Biostatistician to lead statistical activities in clinical trials. This individual will uphold high standards of scientific rigor and ensure regulatory compliance while working closely with teams across clinical data management, programming, and medical writing.
Key Responsibilities
Contribute to study design and draft statistical sections of clinical trial protocols
Perform sample size and power calculations; generate randomization schedules
Develop and review Statistical Analysis Plans (SAPs) and table shells
Conduct statistical programming to generate efficacy-related tables, listings, and figures
Review statistical output for accuracy and completeness
Conduct literature reviews to support statistical methods
Ensure adherence to internal guidelines and external regulatory standards
Participate in client and regulatory audits
Contribute to interpreting clinical trial results and assess clinical relevance
Collaborate with cross-functional teams throughout the project lifecycle
Qualifications
Master’s or Ph. D. in Biostatistics, Statistics, or related field
At least 5 years of experience in clinical trial biostatistics within a CRO or pharma environment
Proficient in SAS and/or R
Strong understanding of statistical methodologies including linear regression, survival analysis, and Bayesian approaches
Experience analyzing and interpreting clinical data
Familiarity with statistical analysis plans and research study design
Excellent analytical and problem-solving abilities
High attention to detail and accuracy
Strong communication skills, with the ability to explain complex statistical concepts to varied audiences
Capable of working independently and in a team setting
Preferred Skills
Experience with CDISC standards (SDTM, ADa M)
Knowledge of regulatory guidelines (FDA, EMA, ICH)
Strong interpersonal and project management skills
Experience mentoring junior statisticians and contributing to SOPs, templates, or standards
