
Principal Statistical Programmer
Develop and validate statistical programs to support the analysis and reporting of data from clinical and nonclinical studies in support of all corporate therapeutic program areas. Assist in the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards. Create and validate SDTM and ADaM datasets, associated specifications, and associated submission deliverables in compliance with published industry standards and project/study specific requirements. Support the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports. Manage study deliverables ensuring that timelines are met and expected quality is attained. Train and/or mentor junior level programmers. Liaise with Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements.
A minimum of 7 years of experience working in the biotech/pharmaceutical environment is required.
Knowledge of regulatory requirements for dataset submissions
Demonstrable expertise with CDISC CDASH, SDTM, ADaM, DEFINE-XML, and/or controlled terminology
R
Time Management Skills
SAS programming skills
Clinical development process
SAS analysis and reporting
Process Improvement
Driven and self-motivated
Communication Skills
Detail oriented and highly organized
According to JobzMall, the average salary range for a Principal Statistical Programmer in 10222 Barnes Canyon Rd, San Diego, CA 92121, USA is $107,000 to $160,000. This range is based on the salaries of professionals with five to ten years of experience in the field.
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Neuropeptide Receptor Targeted Therapeutics for the Treatment of Endocrine Diseases and Cancers. Crinetics is driven by a passion for drug-hunting and tempered by a post-recession startup culture. The goal is to create new therapeutics that can make a meaningful difference in the lives of our patients.

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