Biostatistician

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Job DescriptionAs a biostatistician, you will provide expert statistical input and contribute to development plans, study design, protocol writing, statistical analysis, and interpretation of clinical study results.
You will be responsible for delivering high-quality analysis results in a timely manner to support decision-making.
You will also provide statistical oversight and guidance to teams and outsourcing partners.
Tasks and Responsibilities:Provide statistical input to the design, analysis, and interpretation of clinical studies, collaborating closely with stakeholders such as clinical representatives, safety teams, and data management teams.Write and review key clinical and statistical documents including protocols, SAP, DMP, CRF, CSR, and others.Ensure the delivery of high-quality and timely statistical analysis results to support decision-making processes.Serve as a statistical representative within cross-functional study teams and project sub-teams, providing support and solutions.Support interactions with health authorities and contribute to submissions, briefing books, and publications.Assist in internal process improvements and development of new statistical capabilities.Maintain current scientific and regulatory knowledge in the field.Required Competencies:Master's or PhD in Statistics or a related field.Experience as a statistician in the pharmaceutical industry.Proficiency in English (oral and written).Good programming skills in SAS (Macro, SQL) and R (functions, packages).Strong knowledge of statistical methodologies applied to clinical and preclinical projects.Ability to propose and implement new statistical methodologies.Excellent knowledge of GCP and ICH guidelines.Strong communication skills, able to explain complex statistical concepts to non-statisticians and build relationships with stakeholders.Leadership qualities to lead statistical and programming teams.Ability to manage, drive, and meet project timelines.Team-oriented, capable of working in multidisciplinary teams.Excellent understanding of regulatory requirements related to statistics (e.g., ICH E9/E10).Technical knowledge of CDISC standards (ADaM, SDTM).Extensive experience in submission processes and interactions with health authorities.
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