Clinical Data Specialist
3 weeks ago
Apex Systems is seeking an experienced Statistical Programmer/Scientist to work with one of our Fortune 100 clients
Job Title: Clinical Data Scientist
Location: Burlingame, CA
Schedule: 3 days onsite, M-F 40 hours a week
Duration: 12 month W2 contract, potential for extensions and conversion.
In this role, you will work in and closely with interdisciplinary teams of product managers, engineers, clinicians, researchers, and other senior clinical research data scientist / biostatisticians. In order to plan and execute research and validation of novel digital approaches to measuring and improving health and wellness for a wearable device. The ideal candidate will have experience/expertise in the development and execution of statistical analysis plans and analytic programming and reporting for clinical/health outcomes research studies, clinical trials, and/or digital health research studies.
Responsibilities:
- Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for research data; advises and assists in the development of inferences and conclusions, as appropriate.
- Execute and evaluate machine learning model performance.
- Assist in the preparation of clinical trial documents, reports, protocols, brochures, scientific abstracts, peer-reviewed manuscripts, and regulatory communications.
- Maintains the highest of clinical research standards to ensure validity and reproducibility of results, performing careful data cleaning activities including handling data discrepancies, missing values, outliers, normalization etc.
- Work effectively across health technology research, engineering, and product, providing analytic expertise that spans traditional biostatistical and data science (e.g. machine learning, signal processing) methods.
- Maintains knowledge of current and emerging trends in data science.
Work focus: Data Infra and Data Standardization following CDISC guidance
Must have qualification:
- 4+ years industry experience
- Experience in developing SDTM/ADaM dataset in a regulatory setting.
- Code experience using Python/R in version control and CI/CD environment.
- Experience in regulatory submission.
- Familiar with CDSIC SDTMIG and ADAMIG documentation
- Motivated and strong execution
- Strong documentation skills.
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