The Associate Director provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. For one or more projects, be accountable for all statistical aspects of protocols and submissions, including quality, relevance to regulatory perspective, and scientific validity. Responsible for facilitating career development of direct reports and assisting VP, BDM and/or Sr. Director, Biostatistics, with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.
With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols. Work with other BDM members or consultants to develop effective statistical approaches applicable to project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.
• Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations. Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations to clients.
• Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project.
• Oversee production of the statistical analyses according to SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings.
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization.
• Provide technical direction and mentoring to staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.
Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in task forces and cross-functional operational excellence initiatives.
Also Acceptable – Ph.D. in statistics or related discipline with 10+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (2+ years), and expertise in one or more therapeutic areas
Experience And Required Skills :
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our client's unwavering commitment to combining good science & good business.