Scientific Specialist - Analytical Method Development And Applied Statistics

We are seeking a Scientific Specialist to develop analytical methods for drug–device combination products and advise project teams on statistical questions. A key focus is to reduce and harmonise sample sizes across projects where scientifically justified.

Key responsibilities

• Develop and validate analytical methods for drug–device combination products and support method transfer in line with internal requirements and international guidelines.
• Develop sampling plans and provide the scientific rationale for reducing and harmonising sample sizes across projects.
• Serve as the first point of contact for project teams working with non-normally distributed data and assess whether data transformations are appropriate.
• Lead efforts to streamline normality testing in standard projects and determine which checks can be reduced.
• Draft an internal guideline defining when reduced sampling plans are scientifically justified.
• Provide statistical input for responses to health authority queries as needed.

Requirements:

• Experience in analytical method development, validation and transfer in a regulated environment.
• Strong applied statistics skills, particularly in sampling design, assessing distributional assumptions and transforming data.
• Ability to explain and document the rationale for statistical decisions in sampling plans, guidelines and technical responses.
• Experience with drug–device combination products is an advantage.