Senior Statistical Programmer

Required Skills & Experience Technical Skills Expertlevel SAS programming skills. Strong, handson experience with CDISC SDTM, ADaM and TLFs . Proven experience developing safety, PK, and PK/PD ADaM datasets . Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows. Solid understanding of earlyphase clinical trial designs , including: Phase I / FirstinHuman Crossover studies Exposureresponse analysis PK parameter pooling Experience 8+ years of statistical programming experience in the pharmaceutical or CRO environment. Demonstrated experience as a Lead Programmer or technical lead. Prior experience working in an FSP engagement model preferred. Experience supporting regulatory submissions is required. Soft Skills Strong communication and stakeholder management skills. Ability to work independently while managing multiple priorities. Detailoriented with a strong commitment to quality and timelines. Preferred Qualifications Experience supporting Translational Medicine or Clinical Pharmacology groups . Familiarity with internal exploratory analysis and earlyphase decisionmaking needs. Exposure to integrated summaries or pooled PK analyses across studies. Required Skills & Experience Technical Skills Expertlevel SAS programming skills. Strong, handson experience with CDISC SDTM, ADaM and TLFs . Proven experience developing safety, PK, and PK/PD ADaM datasets . Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows. Solid understanding of earlyphase clinical trial designs , including: Phase I / FirstinHuman Crossover studies Exposureresponse analysis PK parameter pooling Experience 8+ years of statistical programming experience in the pharmaceutical or CRO environment. Demonstrated experience as a Lead Programmer or technical lead. Prior experience working in an FSP engagement model preferred. Experience supporting regulatory submissions is required. Soft Skills Strong communication and stakeholder management skills. Ability to work independently while managing multiple priorities. Detailoriented with a strong commitment to quality and timelines. Preferred Qualifications Experience supporting Translational Medicine or Clinical Pharmacology groups . Familiarity with internal exploratory analysis and earlyphase decisionmaking needs. Exposure to integrated summaries or pooled PK analyses across studies.