Senior Biostatistician (Ionis Pharmaceuticals, Inc.; Carlsbad, California): Design clinical trials and provide sound statistical guidance on clinical development projects. Provide sample size estimates for proposed studies. Write the statistical section of study protocols, statistical analysis plans, and study reports. Develop clinical trial randomization. Review study protocols, CRFs (Case Report Forms), database structures, study reports, and annual reports. Lead study or project team in the review and discussion of SAP (Statistical Analysis Plan). Oversee and monitor CRO (Contract Research Organization) performance on the implementation of SAP. Maintain study documentation of statistical analyses and supportive documents.
Minimum requirements: Master’s degree or foreign equivalent in Statistics, Biostatistics, or related field plus three (3) years of experience in the position offered, as a Biostatistician, or related occupation.
Must have (skills):
Must have skills and experience with the following:
3 years of experience in SAS (Statistical Analysis Software) programming specifically for statistical analysis in pharmaceutical industry. This includes generating derived analysis datasets and statistical outputs for interim/final analyses, ad-hoc statistical analyses, and sensitivity analyses. Demonstrated experience in implementing CDISC (Clinical Data Interchange Standards Consortium) standards in multiple studies to ensure precise adherence to data standards required by regulatory agencies. 3 years of experience in clinical trial design, actively contributing to study design and protocol development including sample size calculation. Demonstrated application of a diverse range of statistical methodologies to analyze and interpret data to include measurable outcomes including a track record of developing Statistical Analysis Plans (SAP), creating Table, Listing, and Figure shells from study protocols, drafting and reviewing Clinical Study Reports (CSRs) and outputs for clinicaltrials.gov. Experience in the review of annotated Case Report Forms (CRFs).
Any and all experience may be gained concurrently.
Office Address: 2855 Gazelle Court, Carlsbad, CA 92010
Salary: $92,916 - $143,775 per year
Send resumes to: HR, Ionis Pharmaceuticals, Inc. HR@ionis.com Ref: FL81890. An EOE.
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