Associate Director, Statistics

Responsibilities:

• Lead late phase project and regulatory submissions. Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
• Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
• Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.  Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
• Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
• 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.

Qualifications:

Ph.D. with 8 years of experience or MS with 11 years of drug development experience.

Please have experience with adaptive design, interaction with Regulatory Affairs, have hands on skills in programming and be able to think strategically.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.