Senior Biostatistician

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.

Essential Functions

Serve as biostatistics leader for assigned studies and projects

Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation

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

Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables

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

Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines

Good knowledge of CDISC Standards, including SDTM, ADaM

Stay current with emerging statistical methodologies and evolving clinical trial practices

Perform other duties / tasks as required or assigned

Minimum Education, Knowledge, Skills, and Abilities

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

Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application

Experience with regulatory support and interaction

Experience providing statistical oversight of vendors and managing CRO collaborations

Proven ability to manage multiple studies and timeline concurrently

Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians

Ability to work as a team and have skills to convince your position within cross-functional teams

Demonstrated ability to communicate statistical concepts and results clearly and effectively

Interest in and ability to learn clinical drug development processes

Able to work independently with minimum supervision