
Chief Statistical Strategist
2 weeks ago
The Senior Biostatistician is a high-level statistical expert responsible for leading, developing, implementing and overseeing statistical strategies in support of clinical trials.
Key Responsibilities
- Serve as biostatistics lead 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.
Requirements
- Master's degree or PhD in Biostatistics, Statistics or related quantitative field required.
- Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates.
- Proficiency in statistical programming in SAS. Knowledge of R and other programming languages 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 timelines 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.
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