Overview A biopharmaceutical company is hiring for an AD Biostatistician. This level implies significant leadership and strategic responsibility. This is a remote, full-time role. Qualifications Working knowledge of SAS software and an excellent understanding of statistical procedures in SAS Excellent understanding of data (CRF, vendor, SDTM and ADaM), and familiarity with CDISC, ADaM, and SDTM standards Experiences with SAP, TFL shells/specification/review Works collaboratively with programming team and provides clear direction on ADaM/TFL/analyses independently PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction Experienced as study lead statistician and contributing to strategy discussion in cross functional settings Experienced in study level work including authoring SAP and TFL specification Phase 2/3 experience required. #J-18808-Ljbffr Tandym Group
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