Senior Data Analysis

2 weeks ago

India Advanced Clinical Full time
The Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client's R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Serve as biostatistics leader for assigned studies and projects

Author and review Statistical Analysis Plans (SAPs), including mock tables, figures and listings (TFLs)

Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners

Regularly communicate project status to management and escalate issues or risks in a timely manner

Provide statistical input and review for clinical study reports, regulatory documents, and publications

Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards

Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations

Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed

Stay current with emerging statistical methodologies and evolving clinical trial practices

Master's degree or PhD in Biostatistics, Statistics or related quantitative field, required

Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates

Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred

Solid knowledge of statistical methodologies and clinical trial designs

Experience with regulatory support and interaction

Experience providing statistical oversight of vendors and managing CRO collaborations

Interest in and ability to learn clinical drug development processes

Able to work independently with minimum supervision

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