Description
TRAINING & EXPERIENCE-Masters degree/PhD. in Statistics/Biostatistics or equivalent.
-4-6 years for M.S. and 3-5 years for Ph.D. in clinical data experience.
-Major part of work done in office environment.
-Some travel required for project team meetings.
-High degree of accuracy and attention to detail.
-Proficient in SAS and ability to program using SAS macro language.
-Proficient in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
-Excellent project management and organizational skills.
KEY SKILLS & BEHAVIORS
-Work extensively with Biometrics project team members
-Interact with other members of Company and client project teams.
-Respond to questions from clients
-Effectively communicate data findings to the data manager.
-Effectively communicate results to Company and client clinicians and project managers, and client statistician.
-Ability to present statistical methodology and trial results to various audiences.
RESPONSIBILITES
-Manage Biometrics project teams and track department project activities (including project revenue) and provide status updates.
-Represent department on interdepartmental project teams.
-Serve as contact with clients for statistical aspects of clinical studies.
-May serve as project leader for "back-end" projects involving multiple studies.
-Assist in establishing departmental processes, interaction with other departments, training of staff and other departmental administrative duties.
-Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays
-Conduct all statistical analyses in support of clinical research studies.
-Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets.
-Perform quality control of complex efficacy analysis datasets and supervise quality control of safety and all efficacy analysis datasets.
-Perform validation and quality control of complex efficacy data displays and supervise validation and quality control of safety and all efficacy data displays that show inferential statistics.
-Write statistical reports and statistical section of the clinical study report (CSR).
-Write a charter for independent data monitoring committee (IDMC).
-Prepare detailed statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy.
To find out more about Real please visit www.realstaffing.com