Associate Director, Biostatistics

hace 1 día

Barcelona, España AstraZeneca A tiempo completo

**Associate Director, Biostatistics Location**: Barcelona, Spain; This is what you will do: The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, crossstudy statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes, and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data.

**You will need to have**: A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experienceComprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive designregulatory requirements relating to clinical development of drugs and biologicsBLA/NDA experience including eCTD submissionsWorking knowledge of major statistical software programs including SASKnowledge of CDISC requirements for SDTM and ADaMExcellent verbal and written communication skills, and excellent interpersonal skills.The qualified applicant must also be flexible, wellorganized, and possess the ability to work well under pressure.The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: PhD in Statistics/Biostatistics preferred.

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