Remote Senior Statistician – MedTech Regulatory Analytics

RQM+; España; Remote; EUR 70,000 - 100,000; Full time

Job summary

RQM+ is seeking a Senior Statistician to provide statistical consulting and technical support for the design and analysis of clinical studies. Responsibilities include analyzing trial data, preparing SAPs, and collaborating with biostatistics staff to produce interim and final analyses and reports.

The role requires advanced SAS programming, GCP familiarity, and bilingual German/English proficiency. This is a remote position with a global client base and international guidelines adherence.

Qualifications

• Academic degree in mathematics or statistics with several years of experience in a similar role.
• Understanding of Good Clinical Practices (GCP) and AMG rules and governance for early phase trials.
• Advanced SAS programming experience.
• Familiarity with CDISC ADaM and regulatory guidelines.
• Experience creating SAPs and SDTM/ADaM datasets.
• Experience in adaptive interim analyses and final analyses for clinical trials.
• Experience preparing statistical reports and sections of study reports.
• Customer-facing experience and ability to be a client statistician contact.
• Bilingual: German and English.

Responsibilities

• Collect and analyze empirical data from clinical trials and present findings.
• Serve as the biostatistics contact for sponsors of assigned duties.
• Comply with legal requirements and international guidelines and RQM+ policies.
• Draw up statistical analysis plans and tables, and contribute to study protocols and reports.
• Calculate sample sizes and program statistical sections of protocols and SAPs.
• Supervise statistical services and monitor quality of statistical evaluations.

Skills

Bi-lingual (English & German)

SAS programming

Statistical analysis

Clinical trials statistics

Programming with SPSS

Education

MSc/PhD in Mathematics or Statistics

Tools

SAS

SPSS

Job description

RQM+ is seeking a Senior Statistician to provide statistical consulting and technical support for the design and analysis of clinical studies. Responsibilities include analyzing trial data, preparing SAPs, and collaborating with biostatistics staff to produce interim and final analyses and reports.

The role requires advanced SAS programming, GCP familiarity, and bilingual German/English proficiency. This is a remote position with a global client base and international guidelines adherence.