Principal Statistical Programmer
1881 EMD Serono, Inc. - Rockland, MA

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Principal
Statistical Programmer sought by EMD Serono, Inc. to perform the following duties:

Lead a team to perform all statistical programming required for phase 1-4 clinical trials. Independently coordinate programming aspects for clinical trials requiring routine and complex data manipulation and analysis. Independently program (or write validation programs for) and document tables/listings/figures/analysis datasets for clinical trials, integrated safety and efficacy summaries, medical and statistical supervision plans, and statistical analysis plans. Create, validate, maintain, store, and distribute global macros that streamline repetitive and critical operations and increase programming efficiency. Create analysis dataset specifications. Direct/develop statistical programming electronic submission deliverables. Provide statistical programming support for Data Monitoring Committee charters and associated statistical programming deliverables. Plan, communicate, and implement the surveillance of the programming activities performed by a Contract Research Organization. Lead process improvement teams as required, and effectively communicate process improvement developments. Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WI/SOPs. Provide input into statistical programming timelines and resource forecasts for clinical trials. Delegate and coordinate statistical programming activities on a statistical deliverable, ensuring timelines are met and best practices implemented. Mentor statistical programmers.

Requirements include a Bachelor’s degree or equivalent in Statistics, Computer Science, Mathematics, Biostatistics, Biomedical Engineering, Bioinformatics or related field and six years of work experience in the job offered or related field of statistical programming for pharmaceutical projects; or, in the alternative, a Master’s degree or equivalent and three years of work experience.

Special Requirements: Must have expertise in SAS/BASE, SAS/STAT. Must have knowledge of SAS/CONNECT, SAS/MACRO, SAS/GRAPH, SQL. Must have thorough knowledge of relevant regulatory guidelines applicable to clinical development. Must have prior experience with CDISC (SDTM and ADaM).