Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan, study design and data analysis for clinical trials, and regulatory submissions.
Provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximize probability of program success.
Interprets analysis results and ensures reporting accuracy in study reports and regulatory documents, abstracts, posters, oral presentations, manuscripts and written reports to effectively communicate results of clinical programs and studies.
May serve as the point of contact for one or more PSTs within the TA.
Lead or provide oversight to the analysis delivery and quantitative evaluation of clinical trials, and integrated analysis.
Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA), which includes leading written responses to regulatory questions and attending regulatory meetings.

PhD or MS/MA in statistics or related field
10+ years of experience in clinical development within the pharmaceutical or biotechnology industry
Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions
Experience partnering with cross-functional teams and interacting with health authorities
Experience managing external partners (CROs, consultants)

Director Biostatistics – Hematology

Key skills