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Associate Director, Evidence Generation Statistical Programming

Posted 3 days agoViewed

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💎 Seniority level: Director, 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Bachelor's degree preferred; 7 or More Years with Masters degree preferred

📍 Location: United States of America

🔍 Industry: Pharmaceutical

🏢 Company: DSI👥 5001-10000ConsultingSecurityProfessional Services

⏳ Experience: 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Bachelor's degree preferred; 7 or More Years with Masters degree preferred

Requirements:
  • Bachelor's Degree an accredited institution in a science or technical field preferred, Master's Degree preferred.
  • 10+ years of experience in the pharmaceutical industry or CROs with Bachelor's degree, 7+ years with Master's degree.
  • Experience supporting SAS macro or system utility development preferred.
  • Advanced working knowledge of SAS programming language in clinical trials.
  • Knowledge of CDISC SDTM and ADaM standards.
  • Understanding of statistical concepts for clinical trials analysis.
  • Familiarity with drug development phases.
  • Solid background in applied statistics.
  • Knowledge of advanced statistical methods using SAS and R.
  • Advanced knowledge in database structures and setup.
Responsibilities:
  • Support project lead on outsourced projects, act as subject matter expert in statistical programming.
  • Perform programmatic reviews of SDTM, ADaM datasets, and TLFs generated by vendors.
  • Provide programming support for regulatory submissions and develop submission strategies.
  • Create DSI programming standards and templates for datasets and TFLs.
  • Develop and maintain programming macros and tools to enhance efficiency.
  • Evaluate and improve DSI's computing environment system.
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