Warman O'Brien
,
Booker, Buckinghamshire
Associate Director, Statistical Programming
Overview
Job Description
We are looking for an Associate Director, Statistical Programming for a leading pharmaceutical company that focus within oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. This role would play the part of both project and people leader within their Statistical Programming group. This position is responsible for the recruitment, hiring, training and functional management for the set up of a new statistical programming team. Responsibilities: * Design statistical programming strategy across multiple studies within a program and for non-trial activities over the life cycle of a compound/program to ensure consistency, efficiency and proactive problem solving solutions for statistical programming deliverables. * Collaborate with the Statistical lead and other cross functional colleagues to provide input for submission strategy to regulatory agencies and ensures all statistical programming related submission deliverables are complete and compliant. * Statistical programming primary point of contact for trial-related activities. * Represent Statistical Programming and Analysis on the clinical team for cross-trial activities as needed. * Contribute to the development of vendor contracts and R&D Company business planning budget estimates. Oversee vendor management and escalation for projects within their programs. * Evaluate resource demands and ensure updates to functional planning systems. * Anticipation, prevention and early detection of issues impacting statistical programming deliverables for a program. * Collaborate with external partners on statistical programming related deliverables for co-development programs. * Take a leadership role for statistical programming related aspects of regulatory agency inspections and internal audits. * Provide leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. * Provide significant input and/or leadership into the development and maintenance of departmental policies, procedures, training and standards. * Accountable for actively identifying opportunities, evaluate and drive solutions to enhance efficiency and knowledge-sharing at the department level. Qualifications: * In-depth knowledge of programming practices (including tools and processes) and relevant regulatory guidelines. * Project management experience dealing with customers, leading teams to successful outcomes, outsourcing strategies, contract oversight, negotiations and leading through influence. * Experience working on cross-functional teams * Strong communication skills and experience working within a matrix environment. * Excellent leadership, decision-making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment.