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Scientific Specialist – Analytical Method Development, Applied Statistics
avacone Switzerland. Develop and validate analytical methods for drug–device combination products and support method transfer in line with internal requirements and international guidelines.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical method development and validation for drug-device combination products, with a strong focus on applied statistics and sampling design. Capable of providing scientific rationale for statistical decisions and drafting guidelines in a regulated environment.
Highest-signal resume keywords
Analytical Method DevelopmentStatistical Input for Health Authority QueriesSampling Design ExpertiseData Transformation AssessmentDrug-Device Combination Products Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical Method ValidationSampling Plan DevelopmentStatistical AnalysisNormality TestingData Transformation
Soft Skills
Documentation SkillsCommunication Skills
Industry Keywords
Regulated EnvironmentInternational GuidelinesStatistical GuidelinesNon-Normally Distributed DataHealth Authority Compliance
About the role
Key responsibilities & impact- 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
What you’ll need- 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.