Vacancies
Senior Principal Scientist - Biostatistics
Job Introduction
Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.
The Opportunity
The primary function of the Senior Principal Scientist, Biostatistics will be to apply statistical methods to produce rigorous analysis of and insights into our clinical data to inform key business decisions made by the global Product Development team in their mission to deliver novel drugs and biotherapeutics to the animal health market. The responsibilities can vary day-to-day and can quickly change depending on business needs. Candidates for this position should demonstrate a high degree of learning agility and be passionate about data driven decision making.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Provide statistical support, advice and analysis to animal health development projects in Dechra’s portfolio of novel biotherapeutics and pharmaceuticals. Act as a statistical representative in the planning, organizing and execution of proof of concept and pilot clinical studies, laboratory experiments and pivotal clinical trials according to GCP or GLP principles. Provide scientific input into study design and protocol development, ensuring adequate statistical power and appropriate statistical methodology. Order, collate and interpret large volumes of diverse data. 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 global veterinary regulatory guidance documents, practices and GXP principles. Author statistical documentation in support of submissions to FDA-CVM, USDA, EMA, and other regulatory agencies and support the defence of statistical conclusions to the various agencies as required. Maintain subject matter currency and apply appropriate statistical methodology in all studies.
The Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:
Ability to work successfully in a fast-paced, cross-functional, global environment. Ability to successfully balance priorities to meet project deadlines. MS in statistics, biostatistics, data science, or equivalent with substantial graduate level coursework in statistics. Practical experience in the analysis of data to support animal health clinical and safety programs. Experience with FDA-CVM and/or USDA submissions. Proficiency with at least one computer statistical programming language (SAS®, R, Python) Quantitative and analytical ability Proficiency in MS Office (Excel, Outlook, Word, PowerPoint)
Desirable:
Proven track record of supporting successful development programs in bringing large molecule therapeutics to animal health market Experience with visualization software (e.g. Power BI) Interest in and ability to develop expertise in multiple veterinary therapeutic areas. Proficiency in advanced statistical/machine learning techniques Advanced coursework in generalized linear models, multivariate methods, computational statistics. Familiarity with multiple statistical programming languages and packages. Adept working with large databases Experience supporting CMC statistical needs Knowledge of SQL
