
Lead Statistician
4 days ago
We are seeking a Biostatistician Professional to support the clinical trial lifecycle, from protocol development to Clinical Study Report (CSR). This role involves statistical analysis planning, project coordination, and biostatistics representation on project teams.
Key Responsibilities- Provide statistical support throughout all stages of a clinical trial project, from protocol development to CSR.
- Prepare Statistical Analysis Plans (SAPs) and develop mock-up displays for tables, listings, and figures.
- Coordinate project activities to ensure timely completion of high-quality work.
- Review and provide independent assessment of project work produced by other biostatisticians.
- Create or review programming specifications for analysis datasets, tables, listings, and figures.
- Review data capture processes to ensure all required information is obtained.
- Conduct verification and quality control of project deliverables.
- Manage project timelines and proactively communicate any difficulties to team members.
- Provide statistical programming support as needed.
- Support business development activities through proposal contributions.
- Coach and mentor junior biostatistics staff.
- Adhere to relevant regulatory guidelines (ICH).
- Graduate degree in biostatistics or related field.
- Proven experience in clinical trials with proficiency in programming.
- Ability to apply knowledge of statistical design, analysis, and programming techniques utilized in clinical research.
- Excellent written and verbal communication skills to effectively convey complex statistical concepts.
- Statistical analysis and programming expertise.
- Strong understanding of ICH guidelines.
- Effective communication and interpersonal skills.
- Ability to adapt to changing project requirements.
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