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Method Developer & Statistical Expert (mfd)

Aequor Consulting GmbH

Job Location:

Basel - Switzerland

Monthly Salary: Not provided by the employer

Posted: 5 November 2026 (Yesterday)

Application Deadline: 2 February 2027

Vacancies: 1 Vacancy

Job Summary

Are you an experienced analytical method development and statistics expert with a strong background in pharmaceutical drug-device combination products Do you have in-depth knowledge of international standards and statistical methodologies and enjoy applying your expertise to improve analytical processes and ensure robust scientifically sound results

For a leading international pharmaceutical company in Basel an experienced Method Developer & Statistical Expert (m/f/d) is sought to support Research & Development activities. This assignment offers the opportunity to contribute to analytical method development statistical evaluations and the optimization of sampling strategies within a highly regulated environment.

Responsibilities

Develop analytical methods for drug-device combination products including method validation and transfer activities in accordance with internal guidelines and applicable international standards.
Develop sampling plans and provide scientific justifications to minimize and harmonize sample quantities.
Act as the primary point of contact for troubleshooting statistical challenges particularly regarding non-normal data distributions and appropriate data transformations across the project portfolio.
Lead and implement initiatives to reduce the need for normality testing in standard projects.
Develop internal guidelines for reduced sampling plans supported by scientifically sound justifications.
Provide statistical expertise and support in responding to Health Authority requests where required.

Requirements

Extensive expertise in ISO standards the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) including their interpretation and practical application.
Proven expertise in sample size determination and sampling plans based on fixed patient risk and Acceptance Quality Limits (AQL) particularly in accordance with ISO 3951-2.
Strong experience in analytical method development for drug-device combination products particularly physical and mechanical testing.
In-depth knowledge of analytical method validation and transfer processes.
Advanced statistical expertise in normality assessment and data transformation including practical experience with statistical software such as Minitab.
Excellent verbal and written English communication skills.
Experience with or access to NRV and 1-QEM (Novartis internal systems) is considered an advantage.
Availability during European working hours to ensure effective coordination of work packages and project status updates.