Sr Principal Statistician CMC

HIRING: Sr Principal Statistician CMC, (Similar to Associate Director)

About this Biotech

My client a well established Biotech, pioneers in a range of therapeutics, transforming lives with groundbreaking medicines based on Nobel Prize-winning science. Their culture of fierce innovation, openness, purposeful urgency, passion for excellence, and commitment to people drives their success and recognition as a top global employer.

Overview

Looking for more visibility in your role? My client, a well established Biotech, is looking for someone to join their groundbreaking team as a Sr Principal Statistician in the Chemistry, Manufacturing, and Controls (CMC) department. You'll be at the forefront of advancing therapeutics, applying cutting-edge statistical techniques with multidisciplinary teams, and setting the direction for statistical excellence.

Key Responsibilities

• Innovate and Collaborate: Partner with chemists and engineers to revolutionize process development and characterization using Design of Experiments (DOE) and Quality by Design (QbD) principles.
• Precision and Validation: Lead the charge in validating assays with analytical chemists, using advanced statistical methods to ensure accuracy and reliability.
• Stability and Longevity: Work with stability scientists to determine retest periods and shelf-life, utilizing state-of-the-art ANCOVA techniques.
• Quality and Assurance: Set the gold standard for drug substance and product specifications through sophisticated batch data analysis.
• Empower and Equip: Provide QC and manufacturing teams with top-tier tools for Statistical Process Control (SPC), Capability Analysis, and Out-of-Trend (OOT) detection.
• Data-Driven Insights: Leverage data mining and predictive models to create a platform of process knowledge.
• Leadership and Documentation: Author essential statistical SOPs, guidance documents, and sections of technical reports and regulatory submissions.
• Educate and Inspire: Conduct engaging seminars to enhance statistical literacy and empower partners with advanced statistical tools.
• Stay Ahead: Keep pace with the latest statistical trends, publish innovative research, and represent us at leading industry conferences.

Qualifications

• Expertise and Experience: Advanced degree in Statistics with 5 years of relevant experience (PhD) or 10 years (MS) in the bio/pharmaceutical industry. Alternatively, a primary degree in Chemistry, Chemical Engineering, or life sciences with significant statistical training will be considered.
• Technical Mastery: Proven experience with the statistical techniques and ICH guidance documents relevant to this role.
• Programming Proficiency: Expertise in R programming and fluency in JMP or Minitab.
• Communication Excellence: Outstanding oral and interpersonal skills to effectively collaborate and influence technical teams.
• Written Prowess: Exceptional written communication skills, evidenced by authorship of peer-reviewed publications and technical reports.

Apply to learn more!