Remote Associate Director Biostatistics
- R+D/ Global Development Support
- Remote/Greater NJ area
- Salary range: 150k-190k + additional benefits
A pharmaceutical company dedicated to driving modernization to deliver improved methods to manage pain safely and effectively is seeking an Associate Director Biostatistics. This position will supervise statistical support to multiple project teams. The AD will collaborate with clinical and regulatory in identifying general strategic approach, creating clinical development plans (CDP), and producing individual protocols.
The Associate Director Biostatistics position will have responsibilities that include:
- Operate independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
- Manage implementation of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and construction of overall summaries.
- Review and approve key results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
- Guarantee statistical representation at regulatory or other external meetings. Completed data package appropriate for submission or making key decisions. Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards.
- Provide overall guidance on definition and documentation of key derived variables needed to support construction of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with Sanofi-Aventis standard data models, e.g. CIDSC.
- Scheme and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.
- Guarantee mentoring and development of staff. Promote personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies.
The ideal candidate will have the following skill set:
- PH.D. or Master's degree in Bio-Statistics or closely related discipline from accredited college or university.
- Minimum 5 years of hands on Bio-statistics experience in the Pharmaceutical or Biotech industry; including significant interactions with regulatory bodies and experience in neuroscience area
- Minimum 3 years' experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
- Minimum of 3 years of SAS programming experience.
- Demonstrated leadership, project management, and interpersonal skills
- Excellent written and verbal English communication skills
- Excellent presentation skills to groups of varied size and make up.
- Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
- Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
- Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
