Wallingford TransitionBiostatistician, Global Biometric SciencesPurpose : The biostatistician 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.Primary Responsibilities :
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 BMS 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 BMS 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 methodologyImpact : The Biostatistician 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.
Pharma / Clinical Trials
Ph.D. (or equivalent) in Statistics or related field
5 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