Associate Director, Biostatistics
CSL
Associate Director, Biostatistics
The Associate Director, Biostatistics leads the full scope of statistical contribution to a clinical development program, providing statistical strategies for clinical trials and regulatory submissions. This hybrid role requires a PhD with 8 years or MS with 11 years of drug development experience, with strong expertise in advanced statistical methodologies and regulatory interactions.
Associate Director, Biostatistics
The Associate Director, Biostatistics leads the full scope of statistical contribution to a clinical development program, providing statistical strategies for clinical trials and regulatory submissions. This hybrid role requires a PhD with 8 years or MS with 11 years of drug development experience, with strong expertise in advanced statistical methodologies and regulatory interactions.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area
- Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
- Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews
- Lead statistical strategy for planning and study execution and quantitative evaluation to clinical trials, regulatory submissions, and related documents
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions
- Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents
- Manage outsourcing operations or work with internal statistical programmers within the responsible program
- Ensure timeliness and quality of deliverables by CRO/FSP
- Support or lead improvement initiatives within the department, organization and/or pharma industry
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge