The partner company is looking for a Biostatistician to support life sciences projects, including clinical trials for in-vitro diagnostics, medical devices, and pharmaceutical products. This role involves planning and executing statistical analyses, preparing study datasets, and contributing to the generation of comprehensive clinical study reports.
Requirements
- Strong knowledge of statistical methods and clinical trial data analysis, preferably for in-vitro diagnostic trials.
- Proficiency in SAS programming and other statistical software.
- Familiarity with industry standards for clinical trial data and reporting.
Responsibilities
- Conduct project planning activities including protocol and Case Report Form (CRF) review, sample size calculations, Statistical Analysis Plan (SAP), and programming plans.
- Review project datasets and perform statistical analyses according to the SAP, incorporating client modifications as needed.
- Document all analyses and maintain accurate logs for inclusion in project or study files.
- Prepare tables, listings, and figures for final reports and Clinical Study Reports (CSRs).
- Archive all documentation and ensure compliance with project and regulatory standards.
- Perform additional project-related tasks as assigned in individual Statements of Work.
Other
- Master’s degree in Statistics or Biostatistics.
- Minimum 5 years of relevant experience in clinical trials or life sciences projects.
- Excellent verbal and written communication skills.
- Ability to work collaboratively in cross-functional teams and adapt to changing project requirements.
