Senior Biostatistician
Location: Bangalore, India
Employment Type: Full Time
Job Overview
The Senior Biostatistician is responsible for leading complex clinical studies, regulatory submissions, and integrated analyses while providing advanced statistical expertise throughout the clinical development lifecycle. The role involves protocol development, statistical analysis planning, client interaction, regulatory compliance, project leadership, financial oversight, and mentoring of junior statisticians.
The position serves as a lead statistician for complex studies and ensures delivery of high-quality statistical outputs within timelines and budget while maintaining compliance with industry and regulatory standards.
Key Responsibilities
Statistical Leadership
Lead statistical activities for complex clinical studies, integrated summaries, and regulatory submissions.
Serve as Lead Statistician for assigned studies and programs.
Drive statistical discussions with sponsors, project teams, and stakeholders.
Ensure consistency across studies, protocols, and statistical deliverables.
Participate in Data Monitoring Committee (DMC) activities when required.
Protocol & Statistical Analysis Planning
Contribute to protocol development and review.
Review Case Report Forms (CRFs) and clinical study documentation.
Develop and review Statistical Analysis Plans (SAPs).
Provide statistical input for:
Protocols
Analysis Plans
Table Shells
Programming Specifications
Data Review Activities
Perform and review sample size calculations for complex studies.
Datasets & Statistical Programming Support
Develop and maintain programming specifications.
Oversee analysis dataset derivations and assignments.
Review complex efficacy and safety datasets.
Support creation and quality review of ADaM datasets.
Ensure compliance with CDISC and regulatory standards.
Tables, Listings & Figures (TLFs)
Develop specifications for statistical outputs.
Review and validate statistical tables, listings, and figures.
Ensure consistency and accuracy across deliverables.
Support programming and QC review of complex outputs.
Project & Study Management
Plan and manage timelines, resources, and deliverables.
Forecast resource requirements and project workload.
Identify and manage out-of-scope activities.
Coordinate study activities across multiple teams.
Lead project meetings and provide progress updates.
Client Management
Act as primary point of contact for statistical activities.
Build and maintain strong client relationships.
Provide strategic statistical consultation to sponsors.
Support operational and statistical discussions with clients.
Deliver solutions to complex study and analysis challenges.
Risk Management
Identify project risks and implement mitigation plans.
Manage study-level escalations.
Proactively address quality and delivery concerns.
Support compliance and inspection readiness activities.
Database Lock & Unblinding Activities
Lead database lock and unblinding processes.
Review randomization specifications and schedules.
Support unblinded statistical activities where required.
Oversee junior statisticians involved in unblinded work.
Training & Mentorship
Mentor and train junior statisticians and programmers.
Support knowledge-sharing initiatives.
Develop training materials and educational content.
Serve as Subject Matter Expert (SME) in Biostatistics.
Contribute to conferences, publications, and industry engagement activities.
Financial & Business Management
Support financial management of assigned studies.
Monitor budgets and resource utilization.
Participate in revenue forecasting and EAC reviews.
Negotiate and manage out-of-scope work.
Support business growth initiatives and operational efficiency.
Proposal & Business Development Support
Review and contribute to study proposals and budgets.
Participate in Request for Proposal (RFP) activities.
Support bid defense meetings and client presentations.
Contribute statistical expertise during business development efforts.
Qualifications
Education
Bachelor's Degree in:
Biostatistics
Statistics
Mathematics
Related Quantitative Discipline
Preferred
Master's Degree in:
Biostatistics
Statistics
Related Field
Experience (Minimum Required)
5–7 years of relevant Biostatistics experience.
Experience leading clinical studies and statistical projects.
Strong understanding of:
Clinical Trial Design
Statistical Methodology
Regulatory Requirements
Clinical Drug Development
Required Knowledge
Good Clinical Practice (GCP)
ICH Guidelines
Clinical Trial Methodology
Regulatory Submission Requirements
CDISC Standards (SDTM & ADaM)
Sample Size Calculations
Statistical Analysis Planning
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