Principal Biostatistician

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist in the design of studies and the preparation of statistical analysis plans.

• Analyze pharmacokinetic, clinical, and pre-clinical study data.

• Interpret statistical outcomes from pharmacokinetic, clinical, and related analyses.

• Generate randomization schedules for clinical trials.

• Contribute to scientific literature and the intellectual property of Worldwide Clinical Trials.

• Lead interdisciplinary project teams.

• Manage projects and resolve technical issues utilizing contemporary methods.

• Support clinical activities, method development, and marketing/business development through literature reviews and related expertise.

• Train and mentor less experienced staff.

• Supervise personnel involved in statistical and pharmacokinetic-related tasks.

• Design clinical trials and develop data analysis plans.

• Conduct statistical analyses using suitable methods and software.

• Prepare final report documentation, including text, tables, graphs, and analysis outputs.

• Engage with clients, bioanalytical staff, and clinical personnel regarding study design, statistical analyses, pharmacokinetic data analyses, and data interpretation.

• Identify quality issues or potential concerns, report them, and suggest solutions.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree in a scientific field with 12 or more years of relevant work experience is required.

• A PhD or postgraduate degree in a scientific discipline is preferred.

• Familiarity with corporate policies, goals, and objectives, typically acquired after three months of exposure to Worldwide Clinical Trials’ operations.

• Understanding and application of Good Laboratory Practice (GLP) guidelines and U.S. Food and Drug Administration (FDA) guidance documents relevant to statistical analysis, pharmacokinetic studies, analyses, and reports.

• Exceptional SAS programming skills.

• Proficiency in WinNonlin, nQuery, Microsoft Word, and Microsoft Excel.

• Capability to read, write, and comprehend complex literature.

• Ability to write clear, concise study reports and communicate effectively with clients and Worldwide Clinical Trials personnel.

• Proficient in creating, understanding, and interpreting graphs, tables, and charts.

• Strong organizational and problem-solving skills with the ability to prioritize tasks.

• Ability to interact effectively with superiors, peers, and others, communicating ideas clearly.

• Capability to adhere to and implement Worldwide Clinical Trials’ policies and Standard Operating Procedures, generally associated with three months of experience at Worldwide Clinical Trials.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.