We are seeking a Principal Statistical Programmer to provide statistical programming and analytic support clinical studies.
This position will be responsible for SAS programming and statistical analytics for clinical studies.
* Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; system and database expertise. * Creation and review of programming specifications. * Creation of CDISC compliant SDTM and ADaM datasets, and development of data submission package including define.xml and data reviewers' guide * Strong experience in statistical analysis methods and clinical data management concepts. * Performing statistical analysis, generating analytic reports, Tables/Listings/Figures, and Ad-Hoc outputs in support Clinical Study report and exploratory analysis. * Supervising junior programmers, managing programming vendors, and representing statistical programming group in project meetings
* Requires a Bachelor's or Master's degree or equivalent in Statistics, Applied Mathematics, Computer Science or related field. * BS with 10+ years or MS with 8+ of work experience in pharmaceutical/biotech or related industry. * Oncology or/and regulatory submission experience preferred. * Solid programming background and advanced SAS programming skills required. * Proven knowledge of clinical trials, CDISC standards, regulatory guidance, GCP. * Must be able to work independently as well as part of a team. * Must have good communication skill (verbal and written).
Immunomedics is committed to be a leading, innovative biopharmaceutical company.