This job will act as the lead statistician for multiple projects with any level of complexity and will be the primary contact with the sponsor for all biostatistics related activities on assigned projects. Serves as an enterprise resource for complex statistical questions, study design considerations, and protocol development.
- 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 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, interfacing as necessary with other departmental project team representatives.
- Discusses time estimates for completion of study related activities with stakeholders and management and proactively communicates to 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.
- Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
- Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
- 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.
- Other duties as assigned or requested.
Education, Licenses/Certifications, and Experience
- 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.
Knowledge, Skills and Abilities
- 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, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
- Displays willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business
SCOPE OF RESPONSIBILITY
Does this role supervise/manage other employees?
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