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Astellas Pharma Inc.
Innovative Statistical Scientist Lead (Director Level)Astellas Pharma Inc. • Northbrook, IL
Innovative Statistical Scientist Lead (Director Level)

Innovative Statistical Scientist Lead (Director Level)

Astellas Pharma Inc. • Northbrook, IL
30+ days ago
Salary
$170,000.00–$240,000.00 yearly
Job type
  • Full-time
Job description
Responsibilities :
  • Innovation and Methodological Excellence
  • Provide statistical solutions on statistical designs, statistical analyses, simulation works, and other methodological activities for Phase 1 through Phase 4 studies across multiple therapeutic areas with a good understanding of medical literature, clinical trial, regulatory, and commercial landscape.
  • Have expertise in statistical methodology in early-stage designs, including dose optimization, efficacy and safety monitoring, basket trial design, and quantitative decision-making in oncology while keeping balance exploration, safety, and speed with rigor to inform go/no-go criteria.
  • Ensure the implementation of statistical and methodological activities in all drug developments and clinical trials.
  • Provide the QC of sample size calculation, quantitative decision making (QDM), highly statistical analysis, and simulation work for whole drug developments and clinical trials.
  • Have sufficient statistical knowledge, learning novel methodologies, coding skills (R, SAS, etc), and research experience.
  • Academic Activities
  • Proceed with multiple research projects, providing impacts in the research area and leading the research area as an industry expert.
  • Develop a reliable network of academics, regulatory experts, and industry peers and investigate and share new statistical methodologies.
  • Is a member of external industry and professional organizations, takes important roles at academic conferences, is a committee member, organizes programs and sessions, chairs scientific sessions, and makes presentations.
  • Constantly publish manuscripts in academic journals.
  • Mentorship and Capability Development
  • Mentor statisticians and analytics professionals across QSEG, supporting scientific development.
  • Share knowledge, best practices of novel methodology, and internal and external networks.
  • Mentor long-term and short-term PhD students and post-doctors through internship programs.
  • Contribute to internal training, methodology development, and talent pipeline initiatives.
Requirements

Qualifications:

Required

  • PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline.
  • Minimum of 8 years of industry and/or academic experience in clinical development with increasing responsibility and strategic impact.
  • Excellence in modern statistical methods in clinical trials, including advanced Bayesian methods, adaptive designs, external control arms, seamless designs, efficacy and safety monitoring, and quantitative decision-making (especially in oncology).
  • Strong scientific contributions through publications (at least 10 papers), presentations, and participation in industry/regulatory working groups.
  • Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences.
  • Excellence in statistical software (e.g., SAS, R) and familiarity with simulation tools.

Preferred

  • Familiarity with AI/ML applications in clinical development.
  • Experience working with real-world data sources, including data integration, study design, and interpretation.
  • Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming.
  • Good knowledge of medical literature, clinical, regulatory, and commercial landscape.

Salary Range

$170K – $240K (NOTE: Final salary could be more or less, based on experience)

Benefits:

  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • 401(k) match and annual company contribution
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Referral bonus program
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Innovative Statistical Scientist Lead (Director Level) • Northbrook, IL

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