Associate Director Biostatistics

vor 1 Monat

Mainz, Deutschland Proclinical Vollzeit

Associate Director Biostatistics - Permanent - Remote

Proclinical are recruiting for an Associate Director Biostatistics to join a global biotech company. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

Represent statistics in cross-functional project and study teams in multiple projectsProvide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverablesPerform sample size calculations, develop statistical analysis plans and lead TLF developmentPerform statistical analyses and validate analysis resultsOversee outsourced statistical CRO activities and deliverables ensuring highest qualityDevelop, implement and improve statistical processes and standardsSupport and participate in the development of departmental strategiesInteract with global regulatory authorities

Key Skills and Requirements:

PhD or Masters in statistics or biostatisticsFive years (Master) and three years (PhD) experience in the pharmaceutical industry and/or CRO including submission experienceExcellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and RAwareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinkingPreferred experience with clinical study designs in oncology or infectious diseases

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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