Job Description
Position: Principal Statistician Consultant(Clinical Trials)(CRO-ClinChoice)(REMOTE)(Anywhere in EU)Employment type: Contract for 12 months with possible extensionLocation: REMOTE in UK/EUAbout ClinChoiceClinChoice is a Global CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 3,000 employees globally, a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America, and Europe.Assignments for Principal Biostatistician Consultant are to provide Biostatistical support and work on key client deliverables involving designing and analyzing clinical trials.NOTE-If now is not the right time we would still be very interested in discussing our FSP contract brand for future opportunities. We are a Biometrics CRO that contracts directly with professionals. Feel free to contact us at clinchoice-career@clinchoice.com.Tim Tanaka, Manager - RecruitmentResponsibilities• 3+ years’ experience preferred leading late-phase studies • Modeling experiences such as Mixed Models, Cox Models, Kaplan, Mier Estimates, and Poison Modeling would be a plus· • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.• Responsible for assuring that data for statistical analyses are complete, accurate, and consistent.• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.• Responsible for the validity of the analysis and exploring alternative analysis strategies as needed.• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.• Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.• Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians.• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.Requirements:• MS or Ph.D. in Statistics, Biostatistics, or related field. Ph.D. with 3-5 years of experience or MS with 6-8 years of experience.• Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.• Demonstrated understanding and insight into statistics, drug development process, and relevant FDA regulations.• Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.ClinChoice is an Equal Opportunity Employer / Committed to Diversity