Principal Biostatistician
About The Position
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
Requirements
- 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
Responsibilities
- 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.
- 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.
Benefits
- competitive benefits package
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
