Principal Biostatistician

About the role

Use independent judgment and technical expertise to assist in designing studies; preparing statistical analysis plans; analyzing data from pharmacokinetic, clinical, and pre‑clinical studies; interpreting statistical results from pharmacokinetic, clinical, and related analyses; and generating randomization schedules for clinical studies. Principal Scientists are recognized as scientific leaders in the company. They regularly contribute to literature and to building Worldwide Clinical Trials’ intellectual property and are capable of leading interdisciplinary project teams.

Responsibilities

• Accurately and efficiently perform tasks that are broad in scope
• Use knowledge and judgment to reach well‑defined goals in project management
• Work independently and collaboratively to solve technical problems by implementing contemporary methods
• Assist the clinic, method development, and marketing/business development by applying knowledge, conducting literature reviews, providing information, and offering related support
• Train and guide less experienced personnel in techniques required for work assignments
• Supervise personnel involved in statistical and pharmacokinetic‑related work
• Assist with the design of clinical studies and construct data analysis plans to meet study protocol requirements and maximize information from available data
• Perform statistical analyses on clinical and pharmacokinetic data using appropriate methods and software programs
• Prepare documentation for final reports, including text, tables, graphs, and analysis outputs
• Interact with clients, bioanalytical personnel, and clinical personnel regarding study design, statistical analyses, pharmacokinetic data analyses, and data interpretation
• Identify problems or potential problems in generating quality statistical and pharmacokinetic documents, report concerns to their supervisor, and propose possible solutions
• Perform other duties as assigned

Qualifications

• Familiarity with corporate policies, goals, and objectives, normally acquired after three months of exposure to Worldwide Clinical Trials' operations
• Understands and applies Good Laboratory Practice (GLP) guidelines and U.S. Food and Drug Administration (FDA) guidance documents pertinent to statistical analysis, pharmacokinetic studies, pharmacokinetic analyses, and reports
• Excellent SAS programming skills
• Proficient in the use of WinNonlin, nQuery, Microsoft Word, and Microsoft Excel
• Ability to read, write, and understand complex literature
• Ability to write concise, understandable study reports and communicate clearly with clients and Worldwide Clinical Trials personnel
• Ability to create, understand, and interpret graphs, tables, and charts
• Strong organizational and problem‑solving skills and ability to set priorities
• Ability to interact effectively with superiors, peers, and others and communicate ideas clearly
• Ability to follow and implement Worldwide Clinical Trials' policies and Standard Operating Procedures, normally associated with three months of experience at Worldwide Clinical Trials

Experience

• PhD or postgraduate degree with a scientific focus preferred
• Bachelor's degree with a scientific focus and 12 or more years of relevant work experience required
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Pay

United States of America - $96,500.00 - $191,500.00