Dechra · 2 days ago

Development Statistician

United States

Full-time

Hybrid

Senior Level

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BiotechnologyPharmaceutical

Culture & Values

Hiring Manager

Patryk Wikiera

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Responsibilities

Provide statistical support, advice, and analysis to multiple animal health development projects in Dechra's portfolio

Act as a statistical representative and provide scientific input for the planning, organizing, and execution of proof of concept and pilot clinical studies, laboratory experiments, and pivotal clinical trials according to GCP, GLP, and/or statistical principles

Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies for multiple veterinary products, through all stages of development

Summarize and/or review statistical results to ensure appropriate inference, working with other technical experts (e.g. from Clinical, Safety) to optimize clarity of presentation of key statistical results in study reports

Coordinate with clinical and data management experts to facilitate collection, transfer, and storage of study data, including submission to regulatory agencies

Be familiar with and maintain subject matter currency with global veterinary regulatory guidance documents, GXP principles, and appropriate statistical methodologies

Promote the use of innovative statistical designs and methodology to create efficiencies and balance risk and benefit in the advancement of Dechra's pipeline

When data demands, use novel modeling and simulation techniques and in-depth analyses to enable stakeholders to better understand their results and determine potential next steps

Interact with and seek to influence Regulatory Agencies, principally FDA-CVM, EMA, and VMD, and other relevant regulatory agencies in support of Dechra's development programmes

Provide internal consultancy for cross-functional groups within Dechra including R&D and manufacturing

Develop and maintain a network of trusted external statistical resources to ensure provision of appropriate statistical expertise and support to all projects within the Dechra R&D portfolio in a timely manner

Develop and maintain internal SOPs to establish formal procedures ensuring the quality of statistical aspects of studies

Qualification

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MS in StatisticsBiostatisticsData ScienceEquivalent with Substantial Graduate Level Coursework in StatisticsPractical Experience in the Analysis of BiologicalClinical Data at Least One Computer Statistical Programming Language SAS at Least One Computer Statistical Programming Language R at Least One Computer Statistical Programming Language PythonQuantitativeAnalytical Ability Work Successfully in a Fast-PacedCross-FunctionalGlobal Environment Successfully Balance Priorities to Meet Multiple Project Deadlines