Sr. Biostatistician

Position

: Sr. Biostatistician

Experience

: 6-8 years

Location

: Hyderabad

Mode of Working:

Work from Office (5 days working)

Company Url
:

Position Overview:

Job Description
:

We are seeking an experienced
Senior Biostatistician
to join our client's team. The ideal candidate will have strong expertise in statistical methodologies, biostatistics, and clinical data analysis, with the ability to design and implement statistical models to support clinical research and development.

Key Responsibilities:

• Lead statistical design, analysis, and reporting activities for clinical trials and research studies.
• Collaborate with cross-functional teams including clinical, medical, regulatory, and data management to ensure appropriate statistical input in study protocols, SAPs (Statistical Analysis Plans), and CRFs.
• Perform advanced statistical modeling, including prognostic modeling and data interpretation, to support clinical decision-making.
• Ensure statistical deliverables are of high quality, accurate, and aligned with regulatory standards (FDA, EMA, ICH, etc.).
• Mentor junior biostatisticians and provide technical guidance across multiple studies/projects.
• Contribute to publications, regulatory submissions, and presentations of study results.
• Stay updated with latest statistical methodologies, tools, and regulatory guidance in biostatistics.

Requirements:

• Master's or PhD in Biostatistics, Statistics, or a related quantitative discipline.
• 6–8 years of hands-on experience in biostatistics within pharmaceutical, biotech, or CRO industry.
• Strong expertise in statistical modeling, clinical trial methodology, and data interpretation.
• Proficiency in statistical programming languages (SAS, R, Python) with ability to independently perform statistical analyses.
• Deep understanding of regulatory requirements and statistical principles applied to clinical development.
• Excellent problem-solving, analytical, and communication skills.
• Ability to manage multiple projects, prioritize deliverables, and work in a fast-paced environment.

Skills:

• Experience with adaptive trial designs, Bayesian methods, or real-world evidence analysis.
• Knowledge of data visualization and reporting tools.
• Previous mentoring or leadership experience in statistical teams.