Description

Associate Director, Biostatistics_Compound development
Contract role with FSP
Remote- anywhere in EU/UK

About ClinChoice

ClinChoice is a global CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally.

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.

Summary

The Associate Director, Biostatistics provides expert consultation and statistical advice, as well as, strategic leadership from plan to execution during all Phases of drug development. Provide direction to statisticians on statistical and programming principles and methodology. Perform supervisory and management functions relating to the administrative and scientific activities of statisticians. Develop and direct appropriate and innovative study design, analysis, and reporting of clinical study results. As a formal member of a cross-functional clinical drug development team, plan and implement clinical drug development programs. Major responsibilities and accountabilities include, but are not limited to:

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Responsible for an area of significant corporate impact and line management for a group of highly trained professionals.
• Provide strategic and statistical leadership; lead the statistical group to complete projects in a timely and quality manner.
• Represent statistical group and give expert consultation and advice in project planning and corporate level meetings; identify mission-critical needs of the departments.
• Supervise the activities of statisticians, be proactive in resolving issues and establishing team performance standards to ensure that the team functions with the highest efficiency. Establish effective relationships with clients.
• Establish and ensure the use of standards for the analysis and reporting of clinical study data.
• Contribute to the implementation and execution of the drug development plan, and assist in the determination of strategic objectives for regulatory filing.
• Independently develop statistical methodology appropriate for the analysis of clinical studies utilizing knowledge of regulatory guidelines and statistical methodology.
• Participate in conducting statistical research and developing design, analysis, and innovative statistical methodologies to improve the drug development process.

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field. Ph.D. with 6+ years related experience or MS with 8+ years of experience.
• Strong oral and written communication skills, with the ability to communicate effectively throughout all levels of the organization.
• Demonstrated capability to set clear priorities and effectively manage multiple projects.
• Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
• Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.
• Demonstrated pharmaceutical or related industry experience with clinical trials and interaction with Regulatory Agencies, especially FDA.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity