Biostatistician II

Worldwide Clinical Trials

. Plan, analyze, and summarize results of individual clinical studies or groups of studies .

Posted 10/5/2026full-timeKochi • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Biostatistics and clinical trial study design, with a strong ability to analyze and summarize clinical study results. Proficient in statistical software and regulatory submission processes, while effectively managing multiple projects and deadlines.

Highest-signal resume keywords

Master's Degree In BiostatisticsStatistical Analysis PlansClinical Trial Study DesignStatistical Software ProficiencyProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSample Size CalculationsRandomization SchemesStatistical Tables ProgrammingData AnalysisExploratory Statistical AnalysesRegulatory SubmissionsStudy SpecificationsClinical Data ReportingStatistical Methodology

Soft Skills

Excellent Communication SkillsStrong Organizational SkillsProblem-Solving SkillsInterpersonal SkillsCreative Team Player

Tools & Technologies

Microsoft Office SuiteStatistical Software Packages

Industry Keywords

Pharmaceutical ResearchCRO ExperienceClinical Development ProgramsRegulatory Agency RequirementsProject Forecasting

About the role

Key responsibilities & impact

Plan, analyze, and summarize results of individual clinical studies or groups of studies
Coordinate development and review of regulatory submissions
Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials
Work with project team personnel and vendors to meet project deliverables and timelines for statistical data analysis and reporting
Provide sample size calculations and review protocols for completeness
Provide randomization schemes and appropriate documentation per SOPs
Monitor project budgets and support project forecasting efforts
Serve as project manager when a clinical development PM does not exist
Contribute to departmental initiatives
Serve as subject matter expert for Biostatistics and Programming teams
Provide statistical advice regarding study design, endpoints, sample size requirements, and methodology
Author statistical analysis plans and study specifications
Serve as primary statistical contact for the study/project team
Use regulatory agency requirements and guidance documents to support clinical development programs
Use literature knowledge to provide data analysis and presentation methods for publications and presentations
Lead study team meetings as needed
Perform other duties as assigned

Requirements

What you’ll need

Master's degree, equivalent, or higher in Biostatistics or a related field
Minimum 2 years of relevant work experience
Pharmaceutical research or CRO experience preferred
Knowledge of clinical trial study design
Ability to work independently on multiple concurrent projects
Experience conducting exploratory statistical analyses using statistical software packages
Proficiency with Microsoft Office Suite
Excellent written and oral communication skills
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Ability to work within constantly changing priorities
Ability to handle multiple projects and meet deadlines
Strong interpersonal skills
Ability to deal effectively with individuals at all organizational levels
Commitment to excellence and high standards
Creative, flexible, and innovative team player
Good judgment with the ability to make timely and sound decisions
Ability to travel for meetings or training activities as needed