Job Posting for Statistical Programmer at AMADOR BIOSCIENCE INC
Amador Bioscience is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid- to small-size biotech companies. Key Responsibilities
This individual will be responsible for aligning/merging data sets, apply binding codes, and preparing merged data sets for pharmacokinetic/pharmacodynamic analysis and modeling.
Knowledge of SDTM, ADAM datasets and FDA open CDISC requirement.
Generating and validate datasets, tables, listings and figures based on FDA open CDISC requirement.
Understanding protocol, SAP of non-clinical/preclinical/clinical studies.
Generating tables, listings and figures accounting for the disposition of patients and samples, descriptive statistics of pharmacokinetic variables, and results.
Creating figures to include but not limited to: drug concentration over time, pharmacokinetic parameters over dose, concentration-effect relationship, and efficacy/safety analyses.
Contributing to the clinical study reports and regulatory submissions
Collaborating with project leaders and statisticians on study protocol design and lab data evaluation (eg ADA cutpoint)
Qualifications & Education Requirements
MS or BS degree in pharmaceutical sciences, biological sciences, Computer Science, Statistics, Mathematics or other relevant scientific fields.
Basic understanding of biostatistics
Experienced in data analysis
Able to take directives and work independently
Excellent problem-solving skills
Excellent interpersonal skills
Proficient in SAS programming.
Basic to advanced understanding of R language
Proficient in Microsoft Office like word, excel, Power Point
Salary.com Estimation for Statistical Programmer in Pleasanton, CA
$102,299 to $136,216
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