Executive Director - Head of Biostatistics

Location: Remote

Therapeutic Area: Solid Tumor Oncology

Executive Director - Head of Biostatistics will provide statistical and programming expertise to the development of clinical study designs and in performing data analysis, providing data interpretation and graphical/summary outputs, and contributing to clinical publications and regulatory submissions. This position will contribute to the clinical program, departmental and cross-functional initiatives by working closely with the clinical study team including the medical director, clinical trial management, data management, and other clinical study personnel. Additionally, this role will oversee outsourced activities and deliverables from biostatistics and programming roles, ensuring on time execution and that deliverables are of high quality and met according to the study plan.

Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc. Provide scientifically rigorous statistical input and review of clinical protocols, interpretation of statistical results and scientific publications. Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs. Participate in regularly scheduled meetings that require statistical input. Develop strategies to address health authorities’ inquiries pertaining to biostatistics. Provide programming support across development to support delivery of summarized tabular/graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses. Maintain and modify in-house code.