Reporting to the Director of Biostatistics will be responsible for analyses, and statistical reports to clinical areas and manage project activities. Works closely with programmers to provide specifications for report tables and listings.
- Provides statistical consulting to clinical teams in design of clinical studies (including sample size estimation, power calculation and study conduct) and in the analysis and interpretation of study data. Works on complex statistical problems in which analysis of data requires an in-depth evaluation of various factors.
- Provides statistical methodology section for study protocol, develops statistical analysis plan, performs statistical analysis and drafts statistical report as required. Provide input into clinical study reports. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Develops systematic documentation of methods, results and statistical programming. Statistical programming may include creation of analysis specified in statistical analysis plan and ad-hoc analysis as requested.
- Coordinates the quality-control checking of deliverables (reports, summary tables, and graphs). Independently QC the statistical outputs generated by the study programmer.
- Participates in project team meetings independently, provides statistical expertise to the team and reports meeting discussions/decisions back to supervisor.
- Manages multiple studies in a team and makes sure of consistencies across all studies if they are in a life cycle team. Manages timelines across all studies. Facilitates and manages workload when CROs are involved.
A thorough knowledge of experimental design, general linear model, categorical data analysis and statistical computing. Familiarity with survival time analysis and nonlinear models is a plus.
Prior medical device experience, experienced working in a CRO environment and/or experienced in Anti-infectives, Microbiology, and Virology. Broad knowledge of clinical development; including clinical operations, data management and clinical study report preparation workflow. FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines.
Strong consulting skills require excellent oral and written communications along with good interpersonal skills. Ability to work on teams is critical. Statistical computing in SAS is required. Familiarity with S plus, JMP, and/or WinBUGS is a plus.