Principal Biostatistician
Location: Bangalore / Pune, India
Company: Fortrea
Department: Biostatistics / Clinical Development
Employment Type: Full-Time (Hybrid)
Role Summary
The Principal Biostatistician is responsible for providing statistical leadership and scientific oversight across complex clinical development programs, including NDA submissions and multi-protocol studies. The role involves developing statistical strategies, authoring Statistical Analysis Plans (SAPs), performing advanced statistical analyses, supporting Data Monitoring Committees (DMCs), reviewing clinical study documentation, and contributing to regulatory submissions.
This position serves as a subject matter expert (SME), providing mentorship to junior statisticians, supporting business development activities, and ensuring high-quality statistical deliverables throughout the clinical trial lifecycle.
Key Responsibilities
Statistical Leadership & Clinical Trial Support
Lead statistical activities for complex clinical studies and NDA submissions.
Provide statistical oversight across multiple studies and programs.
Participate in cross-functional project meetings.
Support strategic statistical decision-making throughout clinical development.
Statistical Analysis & Methodology
Develop and review Statistical Analysis Plans (SAPs).
Perform advanced statistical analyses for clinical trial data.
Conduct:
Survival Analysis
Non-Parametric Analysis
Linear & Non-Linear Modeling
Categorical Data Analysis
Perform quality review of statistical outputs and analyses.
Protocol Development & Study Design
Contribute to protocol development and study design.
Develop statistical sections of clinical protocols.
Perform sample size calculations and power analyses.
Review:
CRFs (Case Report Forms)
Study Specifications
Data Collection Plans
Data Monitoring Committee (DMC) Support
Serve as DMC Support Statistician.
Develop DMC Charters.
Participate in DMC meetings.
Support interim analyses and safety reviews.
Randomization & Clinical Trial Methodology
Develop randomization specifications.
Generate randomization schedules.
Support blinded and unblinded study designs.
Ensure methodological rigor in trial execution.
Regulatory & Submission Support
Provide statistical input for:
NDA Submissions
Regulatory Filings
Clinical Study Reports (CSR)
Review statistical sections of submission documents.
Support responses to regulatory queries.
Project Management
Manage:
Project Timelines
Resource Planning
Milestones
Deliverables
Coordinate statistical activities across multiple teams and locations.
Mentoring & Team Development
Mentor junior statisticians.
Review statistical work performed by team members.
Deliver training sessions and knowledge-sharing seminars.
Support competency development within the department.
Business Development & SME Activities
Participate in bid defense meetings.
Support proposal development for new business opportunities.
Act as Subject Matter Expert (SME).
Contribute to process improvements and procedural documentation.
Audit & Compliance Support
Represent the Biostatistics department during audits.
Ensure compliance with:
ICH Guidelines
GCP Requirements
Regulatory Standards
Company SOPs
Required Qualifications
Education
Master's Degree in:
Statistics
Biostatistics
Mathematics
Related Quantitative Discipline
Experience
8+ years of Biostatistics experience in Clinical Research, CRO, Pharmaceutical, or Biotechnology industry.
Experience supporting:
NDA Submissions
Multi-Protocol Clinical Programs
Regulatory Submissions
Advanced Statistical Analyses
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
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Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
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Zagreb |Estonia :
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Tallinn |Hà Nội :
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