Principal Statistician, Oncology - US or Canada (Remote)
Multiple Locations: United Kingdom • California, United States • North Carolina, United States • Illinois, United States • Massachusetts, United States
Requisition Number: 1897
Position Title: Principal Statistician
SUMMARY: The Biostatistician uses 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 trials and other related analyses; and generating randomization schedules for clinical studies at Worldwide Clinical Trials (“WCT”). Principal Research Scientists are recognized as scientific leaders in the company. They regularly contribute to literature and building WCT’s intellectual property. They are capable of leading inter-disciplinary project teams.
Tasks may include but are not limited to:
- 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.
- Assists the clinic, method development, and marketing/business development, as necessary, by applying knowledge, conducting literature reviews, providing information, and other services.
- Ability to train and guide less experienced personnel in the techniques required for work assignments.
- Supervise personnel involved in statistical and pharmacokinetic related work.
- Assist with the design of the clinical studies and constructs data analysis plans to meet the requisites of the study protocol and extract the most information from the 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 Study Managers and Clinical Study Managers concerning study design, statistical analyses, pharmacokinetic data analyses, and data interpretation.
- Identify problems or potential problems in the processes of generating quality statistical and pharmacokinetic documents, reports such problems to his/her supervisor, and proposes possible solutions.
- Follows WCT’s safety guidelines.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
• Familiarity with the corporate policies, goals and objectives; normally acquired after three months of on-the-job exposure to WCT operations.
• Understands and applies GLP guidelines and FDA guidance documents pertinent to statistical analysis, pharmacokinetic studies, pharmacokinetic analysis, and reports.
• Excellent SAS programming skills.
• Proficient in the use of WinNonlin, nQuery, Word, and Excel.
• Ability to read, write and understand complicated literature.
• Ability to write concise, understandable study reports and to communicate clearly with clients and WCT 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 with superiors, peers and others effectively and to communicate ideas clearly.
• Ability to follow and implement WCT’s policies and Standard Operating Procedures; normally associated with three months experience at WCT.
- PhD 6-10 years or equivalent
#LI-RL1 #LI-Remote #IND-RL1
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Principal Statistician, Oncology - US or Canada (Remote)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.