Telecommute Senior Biostatistician

Biostatistician III/Senior Biostatistician (Remote - United States)
Are you a skilled biostatistician looking to make a meaningful impact in clinical development? Join a collaborative, cross-functional team where you'll help shape clinical trial strategy, drive statistical analyses, support regulatory submissions, and influence critical development decisions. This is a fully remote position, and candidates must be located in the United States.
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. 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. 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.
Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate.
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.
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.
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.
Understanding of CDISC standards and implementation guides.
multiple protocols, single indications) including planning for and execution of integrated analyses.
Defends protocols and SAPs at PRC reviews and provides independent reviews.
Master's degree in Statistics or equivalent & = 6 years of industry related experience.

D. in Statistics or equivalent & = 4 years of industry related experience.

Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals.
Ability to be flexible and adapt quickly to the changing needs of the organization.
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.
Project Statistician Specifics
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.

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