Hybrid Principal Scientist: Analytical Methods & Statistics

Michael Bailey Associates GmbH; Basel; Hybrid; CHF 140,000 - 190,000; Full time

Job summary

Michael Bailey Associates is seeking an experienced Principal Scientist for Analytical Development & Statistics in the drug-device sector. The role focuses on analytical method development, validation, sampling strategies, and statistical evaluation to support regulatory responses.

Hybrid work model with 50% remote and 50% onsite in Basel, Switzerland, and involvement in cross-functional teams across quality, regulatory, and development functions.

Qualifications

• Experience in analytical method development for drug-device products.
• Expertise in method validation and transfer.
• Knowledge of ISO standards, Ph. Eur., and USP.
• Experience with sample size determination and ISO 3951-2.
• Advanced statistics including normality assessment and data transformation.
• Proficient in using Minitab.
• Ability to justify statistical decisions in regulated environments.

Responsibilities

• Develop analytical methods for drug-device products, including validation and transfer.
• Ensure compliance with ISO standards, pharmacopoeias, and internal quality requirements.
• Design and optimize sampling plans to reduce sample requirements.
• Provide statistical troubleshooting and guidance for non-normal data and data transformations.
• Lead initiatives to streamline normality testing for standard projects.
• Develop internal guidelines for sampling strategies and analytical approaches.
• Provide statistical expertise across analytical development projects.
• Support regulatory responses from a statistical and scientific perspective.
• Collaborate with analytical development, quality, and regulatory functions.

Skills

Statistical analysis

Analytical method development

Method validation & transfer

Regulatory support

Cross-functional collaboration

Education

Advanced degree in Pharmaceutical Sciences, Chemistry, Statistics, Engineering

Tools

Minitab

Job description

Michael Bailey Associates is seeking an experienced Principal Scientist for Analytical Development & Statistics in the drug-device sector. The role focuses on analytical method development, validation, sampling strategies, and statistical evaluation to support regulatory responses.

Hybrid work model with 50% remote and 50% onsite in Basel, Switzerland, and involvement in cross-functional teams across quality, regulatory, and development functions.