Associate Director - Statistical Programming - Late R&I

Associate Director – Statistical Programming – Late R&I

Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area
Extensive experience in clinical drug development or healthcare
Advanced SAS Programming, CDISC standards knowledge and industry best practices
Excellent interpersonal skills

Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements
Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations
Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
Lead development of standard methodology to improve quality, efficiency and effectiveness
Drives standards development, implementation, and measure compliance to them
Provides inputs to capacity management while supporting recruitment and skill development by providing training and mentorship
Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery
Hold CRO/Partners accountable for the high-quality standards of their deliverables.