Analytical & Statistical Expert

Michael Bailey Associates; 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

Analytical Development & Statistics (Drug-Device Combination Products)

Work Model: 50% Remote / 50% Onsite

Duration: 04.01.2027 – 31.12.2027

We are looking for an experienced Principal Scientist with strong expertise in analytical method development, validation, and statistical analysis within the pharmaceutical and drug-device combination product environment. The successful candidate will support analytical development activities, sampling strategy optimization, statistical data evaluation, and regulatory responses while ensuring compliance with international quality standards and pharmacopoeial requirements.

Key Responsibilities

• Develop analytical methods for drug-device combination products, including method validation and transfer activities.
• Ensure compliance with international regulations, internal quality requirements, and industry standards.
• Design and optimize scientifically justified sampling plans to harmonize and reduce sample requirements.
• Act as the primary subject matter expert for statistical troubleshooting, including non-normal data distributions and data transformation methodologies.
• Lead initiatives focused on reducing unnecessary normality testing for standard project applications.
• Develop and maintain internal scientific guidelines related to sampling strategies and analytical approaches.
• Provide statistical expertise across analytical development projects within a diverse project portfolio.
• Support responses to regulatory authority inquiries from a statistical and scientific perspective.
• Collaborate closely with cross-functional teams across analytical development, quality, and regulatory functions.

Required Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Statistics, Engineering, or a related scientific discipline.
• Extensive experience in analytical method development for drug-device combination products, particularly physical and mechanical testing.
• Strong expertise in analytical method validation and transfer activities.
• In-depth knowledge of ISO standards, European Pharmacopoeia (Ph. Eur.), and United States Pharmacopeia (USP), including practical interpretation and application.
• Expert knowledge of sample size determination and sampling plans based on fixed patient risk and Acceptance Quality Limits (AQLs), particularly according to ISO 3951-2.
• Advanced statistical expertise, including normality assessment, data transformation, and interpretation of complex datasets.
• Hands-on experience with statistical software such as Minitab.
• Proven ability to provide scientific justification and statistical recommendations in regulated environments.

Preferred Qualifications

• Experience working within global pharmaceutical organizations.
• Familiarity with quality and laboratory systems such as NRV and 1-QEM.
• Experience supporting regulatory submissions and health authority interactions.
• Strong stakeholder management and communication skills.