Clinical Application Specialist - Statistical Prog

We are seeking an experienced Statistical Programmer to support clinical trial safety and efficacy analyses. The role focuses on hands on SAS programming, ADaM dataset development, and clinical data analysis. The ideal candidate will have strong knowledge of CDISC standards, including ADaM and SDTM. This position involves interpreting clinical study documentation and generating clinical Tables, Listings and Figures. The candidate will collaborate closely with statistical programmers and statisticians to support clinical trial reporting and submission activities., o Interpret annotated Case Report Forms, SDTM data, Statistical Analysis Plans, and study programming plans to develop ADaM specifications and datasets. o Develop and support ADaM programming for clinical trial analyses. o Create, validate, and review ADaM datasets in accordance with CDISC standards. o Generate and review clinical Tables, Listings and Figures supporting safety and efficacy analyses. o Support clinical trial data analysis and reporting activities. o Collaborate with statistical programmers and statisticians to deliver accurate and high quality programming outputs. o Learn and apply internal programming macros, standards, and processes., o SAS Programming o ADaM Development o ADaM Specifications o CDISC Standards o SDTM o SAP Interpretation o TLF Programming

o 6 to 8 or more years of SAS programming experience supporting clinical trials. o Strong hands on experience developing ADaM datasets and specifications. o Experience interpreting Statistical Analysis Plans and translating requirements into programming deliverables. o 8 or more years of ADaM and TLF programming experience as specified in the job requirements. o Experience generating clinical Tables, Listings and Figures for safety and efficacy analyses. o Strong knowledge of CDISC standards, including ADaM and SDTM. o Clinical trial programming experience in a pharmaceutical or CRO industry environment. o Strong analytical, communication, and collaboration skills. Preferred Qualifications: o Experience in immunology clinical trials. o Experience in rheumatology, dermatology, gastroenterology, or neuroscience studies. o Experience with SAS Studio or SAS Enterprise Guide. o Pinnacle 21 experience. o Experience supporting electronic clinical submissions. o Master’s degree in Statistics. o Experience reviewing and validating clinical TLF outputs. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

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