Remote or onsite in Raleigh, NC; Wilmington, NC; King of Prussia, PA; or Austin, TX
*Must have recent CRO experience
Acts as the lead or back-up statistician for multiple projects with any level of complexity. Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Helps manage clinical trials efficiently by providing accurate and consistent information to both sponsors and Company business/functional units.
• Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. Sample size calculations may require some literature search to ensure that the study assumptions are correct.
• Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor.
• Directs the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department.
• Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician.
• Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
• Discusses time estimates for completion of study related activities with the Lead Statistician or Biostatistics management and proactively communicate to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
• Ensures proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions.
• Generates and/or reviews randomization schedule(s) to ensure there are no errors present and sponsor and protocol requirements are met. Performs ongoing monitoring of actual randomization scheme applied by IVRS/IWRS.
• Displays willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
*Must have recent CRO experience
MS or PhD in Biostatistics or related field. Moderate experience in clinical trials or equivalent combination of education and experience. Experience in SAS programming. Excellent knowledge of statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, and non-parametric methods. Effective written and verbal communication skills. Ability to apply knowledge of basic statistical design, analysis, ICH guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Ability to read, write, speak, and understand English.