Statistical Programmer / Biostatistician

1MED SA; Circolo d'Agno; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

1MED SA is seeking a Statistical Programmer / Biostatistician to lead statistical design, analysis, and programming for clinical studies across Europe. You will ensure data integrity, participate in regulatory documentation, and collaborate with investigators, data managers, and external vendors.

The role combines strategic statistical leadership with hands-on programming and data management to deliver scientifically rigorous results in alignment with sponsor expectations and GCP guidelines.

Qualifikationen

• Master's Degree in Statistics, Biostatistics, Mathematics, Data Science, Life Sciences, or related field.
• Solid experience in statistical analysis applied to clinical research and trials.
• Knowledge of clinical research processes, GCP, and regulatory requirements; familiarity with CDISC is a plus.

Aufgaben

• Statistical Design and Analysis: design, analyze, implement, and report findings from targeted statistical studies.
• Statistical Programming and Data Management: develop, program, manage, and maintain complex statistical databases and datasets; ensure data integrity.
• Clinical Research and Regulatory Support: prepare protocols, SAPs, CSRs, and support regulatory submissions and Health Authority responses.
• Collaboration and Scientific Leadership: build cross-functional relationships and act as SME for research teams and sponsors.

Kenntnisse

Statistical analysis

Cross-functional collaboration

English communication

Project management

Ausbildung

Master's in Statistics/Biostatistics/Data Science

Tools

SAS

R

Python

Jobbeschreibung

About us

1MED SA is a Specialty MedTech and combination product CRO providing clinical, regulatory, quality, biometrics, and medical writing services to healthcare innovators across Europe. Through a cross-functional approach, we support clients throughout the entire clinical research lifecycle, from development to post-market activities.

As part of our continued growth, we are seeking a Statistical Programmer / Biostatistician to join our team and provide scientific, statistical, and analytical expertise across clinical research projects. The role is responsible for the planning, analysis, programming, and reporting of clinical studies, ensuring alignment with Sponsor expectations, study objectives, regulatory requirements, and organizational standards.

The successful candidate will combine strategic statistical expertise with hands‑on programming and analytical execution, working closely with investigators, clinical teams, data managers, and external stakeholders. Through strong cross‑functional collaboration, this position contributes to the delivery of high‑quality clinical research outputs, ensuring scientific rigor, data integrity, and timely completion of project milestones.

Key Responsibilities

Statistical Design and Analysis:

• Design, analyze, implement, and report findings from targeted statistical research studies.
• Provide expert consultation to investigators and researchers on experimental design, statistical methodologies, scientific standards, and research requirements.
• Collaborate with investigators to develop statistical analysis plans and reporting specifications.
• Advise on the selection of statistical methodologies, reliability of measurements, model identifiability, and interpretation of statistical results.
• Apply advanced statistical techniques in support of clinical research studies and scientific investigations.
• Analyze, interpret, and communicate complex statistical information to support evidence‑based decision‑making.

Statistical Programming and Data Management:

• Develop, program, manage, and maintain complex statistical databases and datasets.
• Create, validate, and optimize statistical programming solutions to support study analyses and reporting activities.
• Utilize SAS and other advanced statistical software packages to collect, process, analyze, and interpret research data.
• Ensure data integrity, quality, consistency, and compliance with applicable standards and guidelines.
• Maintain expertise in evolving statistical methodologies, programming practices, and regulatory expectations.

Clinical Research and Regulatory Support:

• Support the preparation of clinical trial documentation, including Protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), Investigator Brochures, scientific abstracts, and peer-reviewed manuscripts.
• Contribute to regulatory submissions and responses to Health Authorities, Institutional Review Boards (IRBs), Ethics Committees, and Sponsors.
• Ensure statistical deliverables comply with applicable regulations, industry standards, and Good Clinical Practice (GCP) guidelines.
• Support the interpretation and presentation of study results for scientific and regulatory audiences.

Collaboration and Scientific Leadership:

• Build and maintain effective collaborative relationships with internal and external stakeholders across multiple scientific disciplines.
• Serve as a Subject Matter Expert (SME) for research teams, committees, Sponsors, and other collaborators.
• Partner with investigators, clinicians, data managers, regulatory specialists, and external vendors to ensure successful project delivery.
• Facilitate communication and alignment among the various parties involved in clinical research and clinical trials.

Qualifications & Skills

• Master's Degree in Statistics, Biostatistics, Mathematics, Data Science, Life Sciences, or a related scientific discipline, or equivalent professional experience.
• Solid experience in statistical analysis applied to clinical research and clinical trials.
• Strong knowledge of statistical methodologies, study design, and data interpretation.
• Proficiency in SAS and/or other statistical software (e.g., R, Python).
• Experience in statistical programming, database management, and analysis of complex datasets.
• Knowledge of clinical research processes, GCP, and relevant regulatory requirements; familiarity with CDISC standards is a plus.
• Strong analytical, problem‑solving, and communication skills.
• Ability to work effectively in cross‑functional and multidisciplinary environments.
• Excellent organizational and project management skills, with the ability to manage multiple priorities.
• Excellent command of spoken and written English.