Associate Director Biostatistics

4 weeks ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Associate Director, Biostatistics

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide.

Job Summary:

We are seeking a highly skilled and experienced Associate Director, Biostatistics to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office in the USA. The successful candidate will provide technical and operational leadership to project teams, manage clinical trial programs/projects, and ensure sound statistical methodologies in study design, sample size estimation, and data analysis.

Key Responsibilities:
  • Work with senior leadership to manage clinical trial programs/projects and provide day-to-day technical and operational leadership to project teams.
  • Coach, mentor, and develop direct subordinate Biostatisticians and Statistical Programmers, and provide technical review and advice.
  • Perform semi-annual and annual performance reviews and develop developmental plans for direct subordinates.
  • Lead statistical and programming teams, interact with clients and internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
  • Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
  • Provide statistical input in protocol design and development, and participate in writing trial protocols and research proposals.
  • Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
  • Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs).
  • 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, and perform overall quality control (QC) review on statistical deliverables.
  • Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in writing abstracts, manuscripts, posters, and presentations.
  • Act as a consultant to less experienced Biostatisticians, and 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, and perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.
  • Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants, and assist in business development activities, including providing cost estimates of statistical and programming services, participating in generation of project proposals and bid defense meetings, and participating in professional trade shows when required.
  • Participate and/or assist in statistical and programming project budget planning, tracking, and reporting, and 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.

Everest Clinical Research Services Inc is an equal opportunities employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, and opportunities for professional growth and development.

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

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