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CSL

Associate Director, Biostatistics

CSL

Associate Director leading statistical efforts for clinical development at CSL Behring. Involves collaboration with regulatory authorities and cross-functional teams to ensure quality deliverables.

Posted 6/17/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $189,000 - $224,000 per yearWebsite

About the role

Key responsibilities & impact
  • Lead full scope of Biostatistics conduct for the responsible program
  • Define statistical strategy and ensure appropriate methodologies applied to study
  • Influence and contribute to clinical development plans
  • Provide statistical thought partnership for innovative study design
  • Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA)
  • Manage outsourcing operations or work with internal statistical programmers
  • Prepare abstracts, posters, oral presentations and written reports

Requirements

What you’ll need
  • PhD with 8 years of experience or MS with 11 years of experience in drug development
  • Experience providing statistical leadership at compound/indication level
  • Demonstrated statistical expertise in clinical development strategy
  • Solid experience in advanced statistical methodologies
  • Leading roles in regulatory submissions
  • Familiarity with regulatory guidance and interactions
  • Strong interpersonal and communication skills (verbal and written in English)
  • Good working knowledge of SAS and/or R
  • Expertise in CDISC, statistical programming, and/or data standards

Benefits

Comp & perks
  • CSL Behring is committed to supporting employee well-being.
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities
  • Incentive compensation and equity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
statistical strategyadvanced statistical methodologiesstatistical programmingCDISCdrug developmentclinical development strategyregulatory submissions
Soft Skills
interpersonal skillscommunication skillsleadership
Certifications
PhDMS