Associate Director, Biostat (DG)
Parsippany, NJ - Pharmaceutical & Biotech - Hybrid - Full time
Date Posted: 10/25/2023
Associate Director, Biostatistics
Hybrid (2/3 days per week)
$180K base, 20% bonus + stock at high value
Associate Director, Biostatistics will provide leadership and guidance as the lead statistician on a project team. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical function representative within company. In some cases incumbent could serve as department leader in specific technical area.
Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project. Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production 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. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions. Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards. Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection & analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with standard data models, e.g. CIDSC. Plan 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. Ensure mentoring & development of staff. Encourage 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. Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards & are consistent with internal SOP. Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas. Effective corporate use of statistical thinking. Efficient processes in clinical development & operations. This position will have supervisory responsibility and may manage 1-5 direct reports. The incumbent will work closely with clinical research and operation, data management, regulatory, publication.
Requires PhD or Master’s degree in Bio-Statistics or closely related discipline from accredited college/university. Minimum 5 years of hands on Bio-statistics experience in the Pharmaceutical/Biotech industry; including significant interactions with regulatory bodies and experience in neuroscience area. Minimum 3 years’ experience in Neuroscience or Pain clinical trials. Minimum 3 years’ experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, & research committees. Minimum of 3 years of SAS programming experience. Demonstrated leadership, project management, & interpersonal skills. Excellent written & verbal English communication skills. Excellent presentation skills to groups of varied size and make up. Demonstrated broad knowledge & superior understanding of advanced statistical concepts & techniques. Proven ability to innovatively apply technical principles, theories, & concepts to pharmaceutical clinical development & life cycle management. Proven success, through previous submissions or interactions, in meeting regulatory guidelines & requirements for drug development. Demonstrated in-depth understanding of the regulatory drug submission / approval process regionally & globally. Proven ability to effectively represent Biostatistics & Programming in multidisciplinary or cross-functional meetings. Proven ability to work in a fully self-directed manner. Proven ability to independently write SAS programs in adherence to clinical & statistical objectives. Demonstrated knowledge of clinical terms, clinical study designs & the drug and/or device approval process. Demonstrated knowledge of the drug/device approval process is required. Ability to travel (overnights required) approx. 20%.
Please contact Darren Gutowski at firstname.lastname@example.org