Senior Director, Biostatistical Consulting

Summary

Join Allucent™ as a Senior Director, Biostatistical Consulting (SrDBiosC) to assist in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department.

Requirements

• Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare
• Minimum 15 years of relevant work experience
• Minimum 10 years of experience in drug development and/or clinical research
• Thorough knowledge of GxP
• Strong familiarity with relevant regulations and guidelines
• GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
• Working knowledge of computer systems, applications and operating systems

Responsibilities

• Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions
• Provide statistical consulting for complex and/or novel statistical analyses
• Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable
• Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study
• Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity
• Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
• Interpret and communicate results for complex statistical analyses and outputs
• Develop and/or review the statistical sections of a study protocol for studies of any complexity level
• Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
• Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
• Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location