Clinical Trials Senior Biostatistician

Social & Scientific Systems, Inc. (SSS), an employee-owned company, has supported public and private sector programs since 1978. We contribute significantly to improving public health around the world.

SSS is seeking a Senior Biostatistician to support commercial and government clinical research studies, and to provide business development leadership in both the commercial and government sectors. You will provide oversight of all statistical aspects associated with clinical research studies, as well as perform statistical analysis, interpret data, and prepare oral and written statistical reports. Your technical leadership will include the coordination of cross-functional project teams, quality control of all quantitative aspects of the trial, and interaction with clients. The ideal candidate will be able to manage working on multiple projects simultaneously, be flexible, and enjoy working with a multidisciplinary team. Excellent oral and written communication skills are essential. Competency in use of standard statistical software packages to perform statistical analyses is required, including SAS and R.

* Provides support to all aspects of the statistical consulting and support for CRO IND/NDA studies under supervision * Provides leadership and contributions in all aspects of business growth within the clinical trials industry, for both industry and government clients * Participates in a highly collaborative environment as an integral member of a clinical project team that creates data displays and data summaries for studies * Creates and oversees statistical programs to support central monitoring of study metrics * Drafts and reviews statistical analysis plans and provides statistical input for analysis of clinical data * Performs power and sample size calculations, and drafts corresponding material for inclusion in protocols * Contributes to the standards and macros in our SAS/ R library * Provides guidance to statistician on multiple projects

* Ph.D. or Masters' Degree in statistics or other related field * Pharmaceutical industry, consulting, or government experience of 10 or more years * Experience with early to late-phase clinical development * Familiarity with ICH guidelines and FDA/EMA guidance * Experience with forward facing communication with commercial and government client base * Strong statistical consulting skills * Sound understanding and application of research and statistical analysis methods, including methods for randomized trials, longitudinal data, and interim analyses of study endpoints * Ability to collaborate effectively with non-statisticians and project managers * Proficient knowledge of SAS and R statistical packages * Effective oral and written communication and interpersonal skills