Sr Biostatistician

Job Description

Job Summary:

Supports all assigned statistical tasks during the lifecycle of clinical trials, from protocol development to Clinical Study Report (CSR). Prepares statistical analysis plans (SAPs), develops tables, listings, and figures (TLFs), and provides programming and biostatistical support for clinical trials. Collaborates with internal teams and sponsors to ensure high-quality deliverables and regulatory compliance.

Key Responsibilities:

- Provide support across all statistical tasks during the project lifecycle, from protocol to CSR.
- Prepare Statistical Analysis Plans (SAPs) and develop mock-up displays for tables, listings, and figures.
- Collaborate with sponsors and coordinate activities of biostatistics and statistical programming personnel.
- Independently review project work produced by other biostatisticians.
- Create and review programming specifications for analysis datasets, TLFs, and other outputs.
- Review SAS annotated case report forms (CRFs), database designs, and study documentation for completeness and protocol compliance.
- Conduct verification and quality control of project deliverables to ensure consistency with SAP and specifications.
- Serve as biostatistics representative on project teams and contribute to internal meetings and discussions.
- Manage multiple projects, timelines, and priorities, proactively communicating challenges to management.
- Identify out-of-scope tasks and escalate to management as needed.
- Provide statistical programming support as needed and participate in Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC).
- Lead integrated analyses projects, attend regulatory meetings, and respond to sponsor queries.
- Follow SOPs, Work Instructions (WIs), and relevant regulatory guidelines (e.g., ICH).
- Maintain organized, complete, and up-to-date project documentation and verification/quality control programs.
- Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
- Coach and mentor junior Biostatistics staff.
- Perform other related duties as assigned.

Qualifications:

- Graduate degree in Biostatistics or related discipline.
- Moderate experience in clinical trials or equivalent combination of education and experience.
- Proficiency in statistical programming (e.g., SAS).
- Knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
- Experience across all statistical tasks required to support clinical trials during the lifecycle of the project.
- Excellent written and verbal communication skills; ability to read, write, speak, and understand English.

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