Senior Biostatistician

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Role: An experienced Senior Biostatistician to play a key role in the analysis, design, and implementation of clinical research projects. The Senior Biostatistician will provide statistical support for studies, including sample size estimation, study design, data analysis, and interpretation of results. The Senior Biostatistician will be responsible for ensuring the validity and accuracy of study data, reports, and publications.

Key Responsibilities:

• Collaborate with cross-functional teams to design, conduct, and analyze clinical studies, including study design, sample size determination, and power calculations.
• Develop statistical analysis plans (SAPs) that outline the statistical methods and analyses that will be employed to support study objectives.
• Provide statistical guidance and support to clinical development teams, including protocol development, data analysis, and interpretation of study results.
• Develop and validate statistical models to address research questions, including predictive modeling, longitudinal data analysis, and survival analysis.
• Perform statistical analysis of clinical data using a variety of statistical software packages, such as SAS, R, and SPSS.
• Conduct simulations to evaluate the power and performance of statistical test methods.
• Prepare statistical reports for presentation to study sponsors, regulatory bodies, and scientific conferences.
• Stay current with emerging trends in biostatistics and clinical research by attending scientific meetings and participating in ongoing education activities.

Qualifications:

• At least a Masters, biostatistics with at least 7 years of experience in clinical research.
• Experience with statistical analysis of clinical trial data and designing clinical trials.
• Knowledge of regulatory requirements as it pertains to biostatistics.
• Advanced skills in SAS, R, or other statistical software packages.
• Strong written and verbal communication skills.
• Experience in collaborative work environments with cross-functional teams.
• Ability to work independently with minimal supervision and manage multiple deadlines.
• Strong analytical and problem-solving skills.
• Oncology and Submissions experience needed.