Description
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.
-Review and approve case report form (CRF) design, data management plan, and edit specifications for a clinical trial.
-Able to present at bid defenses for Biometrics.
-Able to properly review CSRs to ensure appropriate representation of statistical methodology and inference.
-Respond to sponsor audit and ability to write standard operating procedures (SOPs).
-Perform quality control of datasets and data displays for integrated summary of efficacy (ISE); supervise quality control of datasets and data displays for ISS and ISE.
-Produce quality deliverable within timelines and with customer satisfaction.
-Attain effective understanding and use of the ICH Guidelines E3, E9, and E10.
-Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client).
-Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory and that all interim programs and output are deleted at the completion of the project.
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.
-Ability to present statistical methodology and trial results to various audiences.
To find out more about Real please visit www.realstaffing.com