Acts as the lead 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. Serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.
Maintains a good working knowledge of clinical drug development, ICH and other regulatory guidelines, and biostatistics in order to effectively serve as a statistical department resource, mentors biostatisticians on job skills, oversees or develops training plans or materials for Biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.
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. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
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.
Provides input to Standard Operating Procedures (SOPs) development and review.
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.
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.
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.
MS or PhD in Biostatistics or related field. Extensive experience in clinical trials or equivalent combination of education and experience. Experience in SAS programming. Experience with regulatory submissions preferred. 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. Extensive knowledge of the drug development process and FDA and ICH guidelines. Ability to read, write, speak, and understand English.
Primary Location North America - US Home-Based
Job Data Services
Travel Yes, 25 % of the Time
Employee Status Regular