The Senior Biostatistician spearheads statistical innovation and outcomes in clinical trials. This role contributes to the planning, execution and interpretation of statistical analyses ensuring high-quality, timely deliverables.
- Acts as biostatistics lead for assigned studies and projects
- Leverages expertise in study design discussions, including protocol development and sample size estimation
- Authors Statistical Analysis Plans (SAPs) and oversees statistical programming activities
- Provides strategic leadership in vendor oversight and communication with management
- Reviews clinical study reports and regulatory documents for statistical accuracy and compliance
- Liaises with regulatory authorities on statistical issues and provides applicable strategies
- Delivers statistical presentations to stakeholders and regulatory authorities as needed
A master's or doctoral degree in Biostatistics, Statistics or a related quantitative field is required. A minimum of 8 years' experience in clinical trial biostatistics for MS-level candidates; a minimum of 6 years for PhD-level candidates.
Proficiency in SAS statistical programming. Familiarity with R and other programming languages is beneficialIn-depth knowledge of statistical methodologies and clinical trial designsExperience with CDISC standards and regulatory supportDemonstrated ability to manage multiple studies concurrently and communicate effectively