Senior Biostatistician Jobs

I'm seeking an accomplished and meticulous Senior Biostatistician to play a pivotal role in designing, analyzing, and interpreting clinical trials and research studies. Working closely with multidisciplinary teams, you will ensure precise and reliable statistical analyses, providing invaluable insights for evidence-based decision-making.

Responsibilities

• Prepare and present statistical analysis results, including tables, figures, and data summaries, for regulatory submissions, scientific conferences, and internal/external stakeholders.
• Perform exploratory data analyses and present findings to stakeholders.
• Design and develop statistical analysis plans (SAPs) for clinical trials and research studies, including study design, sample size determination, randomization schemes and statistical methodologies.
• Collaborate with cross-functional teams to define study objectives, endpoints, and data collection strategies.
• Ensure compliance with regulatory guidelines and industry standards in the planning, execution, and reporting of clinical trials.
• Validate and review statistical programming code to ensure quality and adherence to statistical analysis plans.
• Stay updated on emerging statistical methodologies and industry trends, applying innovative approaches to enhance trial design and analysis.
• Conduct statistical analyses using advanced statistical methods, ensuring accuracy and reliability of results.
• Mentor and provide guidance to junior biostatisticians and statistical programmers.
• Provide statistical input and review for clinical study protocols, case report forms (CRFs), and other study-related documents.

Requirements

• Familiarity with regulatory requirements
• 5+ years of experience in the pharmaceutical industry or CRO
• Proficiency in statistical software packages (e.g., SAS, R, or similar)
• Strong knowledge of statistical methodologies and their application in clinical research
• Strong attention to detail and the ability to manage multiple projects simultaneously
• Master's or Ph.D. degree in Biostatistics, Statistics, or a related field
• Demonstrated leadership abilities and the capacity to mentor and guide junior team members