Job Description

Role Description

The non-clinical Statistician will employ statistical design, tools, and techniques to support process, analytical method and formulation development of medical or pharmaceutical products throughout their lifecycle.

Key Responsibilities

• Collaborate with subject matter experts to design experimental studies, plan and perform statistical analysis, and document results in technical reports, in support of business decisions, regulatory submissions and compliance.
• Provide statistical support for a wide range of non-clinical applications, including:
  • Particle size and distribution
  • In-vitro bioequivalence assessments
  • Analytical method optimization and validation
  • Process development and platform characterization
  • Stability studies to understand, control, and ensure product quality
• Ensure compliance with regulatory and ISO requirements for the statistical methods employed.
• Develop, implement, and maintain statistical tools used to support product life cycle activities.
• Promote good statistical practice across the team and mentor colleagues in statistical techniques and software tools.
• Stay up to date on best practices, industry trends, and regulatory guidance.
• Support other non-clinical statistical applications, when needed.
• Support regulatory audits by responding to questions during on-site inspections and providing written responses to clarify statistical approaches or perform additional analyses.

Qualifications

• Doctorate Degree in Statistics or a related field plus 2 years minimum of relevant applied statistics experience OR
• Master’s Degree in Statistics or a related field plus 5 years minimum of relevant applied statistics experience OR
• Bachelor’s Degree in Statistics or a related field plus 10 years minimum of relevant applied statistics experience.
• Proficient in non-clinical applications, including particle size and distribution, in-vitro bioequivalence assessments, analytical method optimization and validation, process development and platform characterization, and stability studies to understand, control, and ensure product quality.
• Experience and/or training in design of experiments, including optimization or robustness experimental designs.
• Proficient in statistical techniques commonly used in pharmaceutical manufacturing operations, such as:
  • Statistical Process Control
  • Process Capability Analysis
  • Measurement System Analysis
  • Acceptance Sampling
  • Non-linear and Linear Regression
  • Significance Testing
  • Simulation
• Skills in machine learning or Bayesian methods are a plus.
• Proficient in SAS and/or R programming including data manipulation, macros, functions, statistical and graphical packages, and quality output production; JMP or R-Shiny skills are a plus.
• Good understanding of pharmaceutical development and CMC activities in a regulatory context, including GMP and Quality by Design framework.
• Excellent communication and collaboration skills.
• Demonstrated ability to work independently and pro-actively to deliver top quality work product.

Benefits

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment.
• Good work-life balance.

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