Biostatistician II

Worldwide Clinical Trials; Thiruvananthapuram; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Biostatistician II to plan, analyze and summarize results for single or group studies within the Clinical Development Operations, Biostatistics Team. You will coordinate regulatory submissions and program statistical tables, listings, figures, and analysis datasets for trials.

Responsibilities include collaborating with project teams, providing sample size calculations, randomization schemes, and documentation per SOPs, while mentoring others and supporting

Qualifications

• Knowledge of clinical trial study design.
• Ability to work independently on multiple concurrent projects.
• Lead study team meetings as needed.
• Conduct exploratory statistical analyses using statistical software.

Responsibilities

• Work with project teams and vendors to meet timelines for analysis and reporting.
• Provide sample size calculations and review study protocols.
• Provide randomization schemes and documentation per SOPs.
• Monitor project budgets and assist forecasting.
• Serve as project manager when no dedicated CDPM exists.
• Contribute to departmental initiatives and standards.
• Act as SME for Biostatistics and Programming teams.
• Provide statistical advice on study design, endpoints, and sample sizes.
• Prepare statistical analysis plans and study specifications.
• Be the primary statistical contact for the study team.
• Apply regulatory guidance to support development programs.
• Utilize literature to inform data analysis and presentation for publications.

Skills

Clinical trial design

Statistical programming

SAS/R

Regulatory submission

Project leadership

Communication skills

Job description

Job Summary

The Biostatistician II is a key member of the Clinical Development Operations, Biostatistics Team. The Biostatistician will plan, analyze, and summarize the results of individual clinical studies or groups of studies, coordinate the development and review of regulatory submissions, and program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials.

Responsibilities

• 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 the 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 the primary statistical contact for the study/project team.
• Use knowledge of regulatory agency requirements and guidance documents to support clinical development programs.
• Use knowledge of literature to provide data analysis and presentation methods to support publications and presentations.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Skills

• Knowledge of clinical trial study design.
• Able to work independently on multiple concurrent projects.
• Lead study team meetings as needed.
• Conduct exploratory statistical analyses using statistical software packages.
• Proficient 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.