[Hiring] Non-Clinical CMC Statistician @IQVIA
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.