[Hiring] Principal Biostatistician @Worldwide Clinical Trials

Role Description

The Principal Scientist, Biostatistician does at Worldwide:

• Use independent judgment and technical expertise to assist in designing studies.
• Prepare statistical analysis plans.
• Analyze data from pharmacokinetic, clinical, and pre‑clinical studies.
• Interpret statistical results from pharmacokinetic, clinical, and related analyses.
• Generate randomization schedules for clinical studies.
• Principal Scientists are recognized as scientific leaders in the company.
• Regularly contribute to literature and to building Worldwide Clinical Trials’ intellectual property.
• Capable of leading interdisciplinary project teams.

What you will do

• 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.

What you bring to the role

• 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.

Your 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.

Salary and Benefits

• The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
• United States of America - $96,500.00 - $191,500.00
• The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it is not a guarantee of exact salary.
• The final salary will be determined based on relevant experience, performance, education, and internal equity.
• In addition to base salary, we offer a competitive benefits package depending on location.
• We ensure pay equity and transparency and comply with all applicable labor laws.
• Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.