Senior Biostatistician

Acldigital; Chennai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

A clinical research firm in Chennai, India is seeking an experienced clinical research professional with a Ph.D. or Master's degree. The candidate will collaborate with clinical investigators, write protocols, and oversee statistical plans and quality control processes. Responsibilities include ensuring communication of project milestones and generating study reports. This role requires 7-12 years of experience in clinical research and strong statistical analysis skills.

Qualifications

• 7-12 years of experience in clinical research or related field.
• Proven expertise in statistical software and analysis.
• Experience in writing protocols and regulatory submissions.

Responsibilities

• Collaborates with clinical investigators to determine study design.
• Writes sections of protocols that require statistical input.
• Leads the project team’s development of statistical analysis plans.

Skills

Statistical analysis

Protocol writing

Project management

Quality control processes

Education

PH.D

Master of Science (M.Sc)

Job description

Experience Range

7 - 12 Years

Qualification

PH.D, Master of Science (M.Sc)

Responsibilities

• Collaborates with clinical investigators to determine study design.
• Writes sections of protocols that require statistical input.
• Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
• Generates treatment allocations in randomized clinical research studies and ensures proper implementation.
• Leads the project team’s development of statistical analysis plans and programs to perform analyses and display study data.
• Performs statistical analyses, writes and validates application programs.
• Implements data and safety monitoring reports to ensure participants safety.
• Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center.
• Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies.
• Applies, guides, and ensures others on team are implementing QC processes, ensuring deliverables are accurate, are of high quality and delivered on agreed timelines.
• Authors or contributes to manuscripts and/or scientific presentations.
• Participates in professional development activities both within and outside the company.
• Ensures timely and effective communication of project milestones and status to internal stakeholders.
• Assists the cross functional communication for smooth deliverables of study related documents.