CAT Technologies Ltd · 2 days ago
Statistical Programmer
United States
Full-time
Remote
Senior Level
$34.62/hr - $40/hr
5+ years exp
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Responsibilities
Represent Biometrics on projects and study teams.
Lead statistical programming deliverables including: generation of data visualizations or summary reports to support internal decision-making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.); providing input for statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design, data review plans, and external data transfer specifications; collaboration with the study team to review data and manage timelines; oversight of Biometrics CRO deliverables.
Design, develop, and validate CDISC analysis data (i.e., SDTM, ADaM) for use with statistical reporting code and analytics applications.
Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries in clinical study reports.
Work with the Biometrics Team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.
Support the Biometrics Team in efforts to build, maintain, and continuously improve an R infrastructure that is suitable for regulatory submission work.
Qualification
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Required
At minimum, a bachelor’s degree in Statistics, Biostatistics, Data Science, Mathematics, or a related field is required.
At least five years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
Demonstrated ability to effectively lead projects and collaborate cross-functionally.
Exceptional R programming skills (including tidyverse, RMarkdown, Shiny, HTML widgets, development of R packages, working with IT staff to build R infrastructure), experience applying software development concepts, well versed in reproducible research methods, and proficiency in using code repositories like Git/GitHub (or similar tools) for collaboration and versioning of operational, robust, and well documented code.
Able to work in a Linux/Unix environment (including shell scripting).
Applied experience with SDTM or ADaM CDISC data.
Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.
Preferred
Prior work experience with experience with regulatory submission of CDISC data, clinical trials in the neuroscience field, working pharmacokinetic/pharmacodynamic data, proficiency in SAS and other languages (e.g., Python, Java, C++, MATLAB), experience with Amazon Web Services and cloud infrastructure, Docker containerization.
Company
CAT Technologies Ltd
CAT Technology Inc., established in October 1999, is engaged in providing quality consulting services in Systems Analysis, System Design, Database Administration, Systems Engineering, Systems Maintenance, Systems Testing, Systems Architecture, Systems Administration, Systems Integration, Technology Migration and other emerging technologies.
201-500 employees
H1B Sponsorship
CAT Technologies Ltd has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (9)
2022 (10)
2021 (20)
2020 (12)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
