Senior Statistical Programmer
External Website Ad – to be posted for minimum 90 calendar days
AstraZeneca Pharmaceuticals LP
Senior Statistical Programmer(s) / Gaithersburg, MD (multiple positions available /full-time/ Mon-Fri / 40 hrs/week) – Responsible for programming clinical trial analysis deliverables following established standards and processes. Review and provide input to a clinical study protocol, Statistical Analysis Plan, Statistical Programming Plan, Case Report Forms and external data transfer agreements. Develop and maintain SDTM and ADaM specifications. Program SDTMs, ADaMs, tables, figures, and listings according to specifications. Work with study team members including but not limited to the clinician, biostatistician, data manager, and medical writer. Provide accurate programming time estimates to management or a study team. Contribute to standards or process improvements.
Requirements: Must have a Bachelor’s degree or foreign equivalent in Biostatistics, Mathematics, Statistics or a related quantitative or analytical field plus three (3) years of experience in the position offered, Statistical Programmer or a related role. Employer will accept a MA degree in a stated field of study in lieu of a BA degree. Must have three (3) years of experience within the pharmaceutical industry with: SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL; CDISC Standard to develop specifications and SAS programs for the creation of SDTM and ADaM data sets as well as the supporting documentation and complex statistical analysis reports; Clinical data structures, relational database structures and complex data systems, case report forms and nonstandard third party data structures; Designing and developing complex programming algorithms for different therapeutic diseases; Regulatory agency guidance including 21CFR Part 11 and ICH-GCP; Programming in R, S-PLUS, VBA, or Perl; Clinical development process, clinical study protocol, statistical analysis plan, statistical programming plan, and statistical tests.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.