TRAINING & EXPERIENCE
KEY SKILLS & BEHAVIORS
- M.S./Ph.D. in Statistics/Biostatistics or equivalent discipline
- 1−3 years experience in the analysis of clinical data for M.S. 0−2 years experience in the analysis of clinical data for Ph.D
- No special physical demands
- Some travel required for meetings
- Major part of work done in office environment
- Proficient in SAS
- Work extensively with Biometrics project team members.
- Interact with other members of Company project team.
- Respond to questions from clients.
- Effectively communicate data findings to the data manager and results to Company clinician, project manager, and sponsor staistician.
Statistician who should be able or is learning to perform all basic analysis and is gaining exposure to more complex analysis for a clinical
- Conduct basic and assist with complex statistical analysis in support of clinical research studies as specified in statistical analysis plans, including statistical graphics.
- Verify randomization codes for a basic study design and develop randomization specifications for basic and complex study designs.
- Prepare statistical sections of protocols (including sample size determinations)and statistical analysis plans.
- Prepare and annotate safety and basic and complex efficacy shell data displays.
- Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets.
- Perform and quality control of data displays that show basic and complex inferential statistics.
- Perform quality control of safety and efficacy analysis datasets.
- 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.
- Handle miscellaneous tasks as assigned by management.
- Able to review case report (CRF)design, data management plan, and edit specifications for a clinical trial.
- Able to review clinical study report (CSR)for statistical concerns.
- Able to provide input to standard operating procedures (SOP)and audits.
- Able to mentor new hire statisticians.
- Able to propose solutions to problems that arise while performing tasks.
- Perform quality control of datasets and data displays for integrated summary of safety and efficacy.
- Produce quality deliverable within timelines and with customer satisfaction.
- Develop effective time management skills.
Theorem Clinical Research - 2 years ago
Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...