Biostatistics Oncology TA Head
Core
Define enterprise-level strategy for biostatistics in oncology, representing the function to regulators and industry groups while driving innovation and organizational transformation.
Role type
Executive Therapeutic Area Head (Biostatistics)
Builds
Enterprise biostatistical strategy, policies, SOPs, and regulatory/HTA/medical strategies for oncology drug development.
Domain
Biotechnology / Oncology / Clinical Statistics
Required skills
Strategic planning, regulatory science, study design, statistical analysis, team leadership, policy development, cross-functional collaboration, KOL engagement, signal detection, life-cycle safety management.
Preferred skills
International collaboration, scientific publications, global team management, life-cycle drug development, regulatory submission experience, statistical software expertise.
Technologies
SAS, R, Python, SQL, CDISC standards, regulatory submission platforms.
Responsibilities
Set and lead biostatistical strategy for Oncology TA; advise cross-functional leaders on statistical strategies; implement new pragmatic methodologies; provide statistical consultancy and training; develop and manage SOPs and policies; oversee KDE, protocols, SAPs, CSRs, and regulatory documents; influence priorities via KOL relationships and publications; align staff with company priorities; lead decisions on statistical differences of opinion; manage technical and good practice oversight; provide strategy on signal detection and life-cycle safety activities.
Seniority
Executive, strategic leadership & mentorship