Penfield Search Partners
Contact: Barbara Day 201.784.9028 firstname.lastname@example.org
Summary: The Associate Director, Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBS Biostatistics Lead, the GBS Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBS Lead.
- Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
- Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
- Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
- Translates scientific questions into statistical terms and statistical concepts into layman terms
- Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
- Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
- Communicates effectively with clinical and regulatory partners and external opinion leaders
- Builds the external reputation of company R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
- Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
- Compliant with company processes and SOPs, global and project standards, and responsible for quality of deliverables
- Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
- Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
- Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
- Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBS Lead for resolution
- Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
- Keeps up-to-date with state-of-the art applied statistical methodology
Impact: The Associate Director II, Biostatistics is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.
- Ph.D. (or equivalent) in Statistics or related field
- >7 years Pharmaceutical/R&D or other related experience, including supporting regulatory filings
- Experience planning and preparing for regulatory meetings
- Expertise in statistical / clinical trials methodology as it relates to clinical development
- Capability to solve complex statistical problems
- Extensive data analysis planning, execution and delivery experience including co-ordination across multiple protocols