Associate Director, Biostatistics

5 days ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Associate Director, Biostatistics (Statistical Operations)  for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities:

Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.

Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.

Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.

Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.

Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.

Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.

Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

Review and provide input to clinical data management deliverables, including but not limited to the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan (DMP).

Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). Perform peer review of SAPs and other technical documents written by others.

Perform hands-on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.

Validate core statistical tables, listings, and figures programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall quality control (QC) review on statistical deliverables before they are released to the clients.

Review and confirm ADaM dataset specifications. Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.

Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.

Act as a consultant to less experienced Biostatisticians.

Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.

Interact with regulatory agencies and support Sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the Sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation (e.g., CDISC).

Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.

Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.

Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.

Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.

Demonstrated exceptional ability and performance.

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