Associate Director of Biostatistics

Overview

An Associate Director of Biostatistics is responsible for overseeing all biostatistics activities for Advanced Clinical.

Responsibilities

Managerial Responsibilities

  • Train, monitor, and supervise the biostatistics team
  • Coordinate teams and assignments of resources across projects and ensure all projects stay on target
  • Ensure overall quality biostatistics deliverables
  • Conduct performance evaluations for direct reports, including guidance toward reaching organizational and career goals
  • Inform management of projects status, statistical issues and employee issues
  • Assist in monthly revenue reporting for biostatistics
  • Understand the Advanced Clinical (AC) overall financial plan and our contribution to and support of AC’s overall financial goals
  • Maximize productivity of direct reports to meet/exceed AC budget goals
  • Write training and establish training programs for new processes
  • Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop processes
  • Other global management responsibilities as requested by the Director of Biostatistics

Standard Operating Procedures (SOPs)

  • Be familiar with and follow department SOPs
  • Ensure staff is adequately trained on and following SOPs
  • Create, revise and review SOPs to recognize and prevent potential regulatory issues

Business Development

  • Assist with RFP/RFI completion
  • Attend sales meetings as requested by Business Development

Statistical Responsibilities

  • Apply knowledge of statistics and drug development to fulfill primary duties
  • Implement and support CDISC, ICH, and other regulatory standards
  • Review protocols, CRFs, and database structures
  • Prepare, review, and approve statistical analysis plans to ensure that appropriate statistical analyses are proposed and implemented
  • Provide statistical support for Independent Data Monitoring Committees and interim analyses
  • Ensure the accuracy, quality, and appropriateness of the statistical tables, listings, graphs, and derived datasets for Clinical Study Reports and for other regulatory filings, including IND annual reports and Integrated Summaries of Safety and Efficacy
  • Effectively communicate statistical concepts and arguments to colleagues, clients, and regulatory agencies

Additional Responsibilities

  • Participates in the management team responsibilities as assigned by management

Qualifications

  • PhD or Master’s degree in Statistics or a closely related field
  • Applicable Standard Operating Procedures
  • Good Clinical Practices (21 CFR; Guidance Documents including ICH Guidelines)
  • Drug Development and Approval Process
  • Minimum of 8 years’ experience in pharmaceutical development and SAS programming for statistical analysis
  • Minimum of 2 years of management experience in a pharmaceutical of CRO
  • Candidate must have experience in clinical trial design and be familiar with regulatory requirements
  • Excellent oral and written communication skills, project and personnel management skills, and organizational skills are required.


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