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Associate Director Biostatistics

2 months ago

United Kingdom Warman O'Brien Full time

Associate Director Biostatistics - Modern Thinking CRO - UK/Remote

We have recently partnered with this forward thinking, CRO, who are looking for biostatisticians to join their team, to expand their outreach in the UK / Europe.

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
  • Perform semi-annual and annual performance review and develop developmental plans contributing to the performance evaluation process.
  • Lead statistical and programming teams, interact with clients and/or company 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 or a Master’s degree in these fields

Demonstrated exceptional ability and performance.

Interested? Drop me a message or send your CV to aimee@warmanobrien.com receive more details surrounding this role and discuss this further