Amgen

Associate Director, Biostatistics

Amgen

full-time

Posted on:

Origin:  • 🇺🇸 United States

Visit company website
✨ AI Apply
Manual Apply

Salary

💰 $175,519 - $207,953 per year

Job Level

Senior

Tech Stack

Flash

About the role

  • Provide support for Precision Medicine and implement exploratory biostatistical strategy
  • Execute statistics strategy, implement standards and approaches for exploratory analysis planning and analyses
  • Advise and lead statisticians on techniques for robust analysis and conclusions
  • Serve as product or disease area exploratory analysis lead as needed
  • Plan and implement statistical activities for exploratory SAPs, reports and publications
  • Implement, lead and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
  • Oversee statistical contributions to SAPs, TFL shells, submission data file specifications and other study documentation
  • Collaborate cross-functionally to deliver analysis results in TFLs, Flash Memos, CSRs, publications and other communications
  • Serve as EBG lead on EGT or CST with exploratory analysis needs
  • Contribute to clinical publications, regulatory filing documents, reimbursement documents
  • Provide statistical consultancy, training, and advice within Amgen
  • Participate in process improvement initiatives and oversee FSP statisticians

Requirements

  • Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
  • At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research (preferred)
  • Life Cycle Drug Development Experience
  • Life Cycle Diagnostic Development Experience, clinical trial biomarker (CTA) and companion diagnostic (CDx) co-development experience (preferred)
  • Regulatory interaction experience with global regulators (e.g., CDER and CDRH) (preferred)
  • Statistical leadership and contribution to regulatory submissions and publications
  • Statistical expertise in exploratory biomarker analysis
  • Thorough understanding of regulatory and industry guidelines, trends and good practices
  • Strong oral and written communication in English
  • Experience working in a globally dispersed team environment
  • Independent leadership on projects
  • Highly proficient in biostatistical software
  • Ability to lead cross-functional teams and manage timelines