Lead complex studies or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
Lead the development of complex SAPs perform senior review of SAPs developed by other statisticians
Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
Present and share knowledge at monthly team meetings and at external scientific meetings and conferences
Attend bid defense meetings
Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
Requirements
Advance degree in a relevant field such as biostatistics, computer sciences, etc. (Doctoral degree preferred)
At least 5 or more years of solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company, ideally with RWE studies
Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
Proven professional experience with SDTMs, ADaM datasets and TFLs
Proven ability to effectively communicate statistical concepts
A good knowledge of the overall observational study process
Competence in the preparation of SAPs, analysis, and reporting
Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail