$70,000–$100,000 Per Year
Statistical Analysis System (SAS), Biostatistics, SQL (Structured Query Language), Statistics, IBM SPSS Statistical Package, Statements on Auditing Standards (SAS), Data Modeling, ADaM, Clinical Data Interchange Standards Consortium (CDISC), SDTM, Administrative Skills, Clinical Assessment, Clinical Data, Clinical Research, Data Analysis, Data Entry,
- Master's or Doctorate degree (e.g., PhD, ScD, DrPH) in Biostatistics/Statistics, Data Science, Bioinformatics, Biological Sciences, Public Health, Math, or a closely related field with relevant experience.
- Familiar with CDISC conventions, i.e. SDTM and ADaM models (using SAS) and related controlled terminologies, and knowledge or some experience using these models
- Excellent programmer in R (including tidyverse) and are proficient working in Git-based environments (e.g., Github, Gitlab)
- Be an analytical thinker and good communicator with experience analyzing real-world data
- Solid experience in creating Tables, Listings, and Graphs using R packages
- Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance from a programming standpoint
- Prepare, update, and maintain all versions of statistical analysis plans.
- Develop and update as required by CDISC Reviewer’s Guides.
- Prepare, update, and maintain all versions of Statistical Programming Validation Plans, and all versions of statistical programming validation reports; Develop and provide statistical program formats used in the statistical programs (all versions).
- Prepare, update, and maintain all versions of randomization plans including randomization list(s) and key(s), prepare statistical programs used to create randomization list(s) and key(s).
- Develop statistical programming specifications (clinical data) and other statistical programs used to produce the tables, listings, and figures for studies.
- Produce data-populated tables, listing, and figures for studies, the Data Monitoring Committee, safety surveillance plans, FDA annual reports, interim analyses (if applicable), and any ad hoc analyses.
- Analysis Data Model datasets conforming to CDISC standards as required.
Flexible Schedule, Work From Home
ClinPharma Clinical Research LLC is seeking clinical data analysts to support the Office of Regulated Activities (ORA), using SAS related skills to regulate the entry level data
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ClinPharma Clinical Research LLC