Position Summary:

The Biostatistician III/ Senior 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 GBDS (Global Biometric Sciences) Biostatistics 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

GBDS Lead.

The Biostatistician III 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 III 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.

Key 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.
• 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’s 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 study team level and escalates lack of team alignment to the GBDS 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.  Understanding of CDISC standards and implementation guides.

Additional, Senior Level Responsibilities and Major Duties:

• Independently leads the development and execution of statistical aspects for multiple or complex studies.
• Leads portions of filing activities (e.g., multiple protocols, single indications) including planning for and execution of integrated analyses.
• Defends protocols and SAPs at PRC reviews and provides independent reviews.

Skills, Knowledge, and Experience:

Minimum Requirements:

• Master's degree in Statistics or equivalent & ≥ 6 years of industry related experience.

Or

• Ph.D. in Statistics or equivalent & ≥ 4 years of industry related experience.

Must Have

• Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.
• Excellent verbal and written communications skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Sr. Project Statistician Specifics

• Extensive knowledge of statistical / clinical trials methodology as it relates to clinical development.
• Demonstrated data analysis planning, execution and delivery experience in multiple clinical development setting, e.g. different diseases, indications, development phase.
• Past submission and regulatory interaction experience.