Our Health Analytics group is seeking a Senior Biostatistician to lead a team of researchers located in Columbus, OH. Health Analytics supports government, academic and private industry clients in the areas of knowledge management of systems related to life sciences research, chemical and material science research, and healthcare. Someone in this role is expected to:
Lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs
Lead business development activities; including capture discussions with clients and proposal development
Lead development of clinical protocols
Provide input into the study design, efficacy, safety parameters, and the planned statistical analyses
Perform simulations to support choice of study design, decision rules, and the sample size
Lead development of statistical analysis plans and mock tables, listings and figures, as well as SAS programming and edit specifications
Support the data analyses and statistical deliverables for one or more clinical trials
Responsible to manage the development and quality of TMF trial documentation.
Oversee clinical trial statistical and programming staff to ensure:Appropriate SAS programs and specifications are developed to generate regulatory compliant deliverables (e.g., SDTM and ADaM data sets/analysis files, and tables, listings, and figures and all eSUB required output)
Ensure all SAS programs, CDISC data sets and all regulatory output are validated and documented as such
Analyses are performed as specified in protocols and statistical analysis plans
Data and statistical deliverables comply with regulatory authority requirements and guidelines
Develop and maintain functional-level standards, SOPs, and templates, as needed, and maintain standards for clinical trial statistical activities
Collaborate with the clinical SAS programming team to develop SAS macro libraries to standardize routine analysis or implement new methods.
Produce and validate Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
Provide publication support for clinical trials as needed
THE FOLLOWING IS REQUIRED
Master’s degree in statistics, biostatistics, or a related field and 4+ years of focused experience in clinical trials or an equivalent combination of education/experience in a relevant field. OR
PhD degree in statistics, biostatistics, or a related field and 1+ years of focused experience in clinical trials
Proficient in programming languages - SAS, Python, R or other statistical packages
Ability to work on multiple projects concurrently
Strong planning skills
Ability to communicate effectively verbally and in writing
Maintain effective working relationships with a broad range of colleagues
Demonstrated ability to work within budget and schedule constraints
Demonstrated ability to work as an effective member of a multidisciplinary team
Good understanding of clinical trial process and clinical technology
Broad technical and/or operational background and must be a self-starter who is willing to take on new challenges.
Experience with a multitude of statistical models.
THE FOLLOWING IS DESIRED
PhD in related field and 5 years of clinical trials experience.
Experience with modeling and simulation, multiple comparisons, and missing data analysis in addition to knowledge of fundamentals in statistics.