Biostatistician | MedTech & IVD

Biostatistician | MedTech & IVD
Porto
Porto, Porto District, Portugal

POSITION TITLE:

Biostatistician | Med
Tech & IVD

Full-time

Remote (Europe-based) with availability to travel

The Biostatistician role at MDx CRO involves providing advanced statistical expertise for clinical trials and regulatory submissions in the medical device , in vitro diagnostics (IVD) , and digital health sectors. You will design and analyse studies, ensuring robust methodology and compliance with international standards.

As a Biostatistician, you will:

• Develop Statistical Analysis Plans (SAP) for clinical studies.
• Perform sample size calculations for diagnostics, therapies, medical devices, and IVDs.
• Design randomisation schemes and ensure statistical integrity.
• Analyse clinical trial data using appropriate statistical methodologies.
• Prepare comprehensive statistical reports for regulatory submissions.
• Collaborate with medical writers and clinical teams to interpret results.
• Ensure compliance with GCP, ISO standards, and applicable regulations.
• Support analytical validation for IVD performance studies .
• Contribute to projects involving Digital Health algorithms and advanced analytics.
• Provide scientific input and assist with project management tasks.

• Master’s or Ph. D. in Biostatistics, Statistics, or related field.
• Proven experience in clinical research, preferably with medical devices and IVDs.
• Expertise in sample size calculation for diagnostics and therapies .
• Proficiency in statistical software (e. g. , SAS, R).
• Strong understanding of GCP and regulatory requirements.
• Knowledge of Digital Health algorithms and analytical validation for IVDs (desired).
• Excellent analytical and
  - solving skills.
• Advanced English (C1–C2 level).
• Ability to work in a
  - paced,
  - stage environment.
• Flexibility for remote work and occasional
  - person activities.

MDx CRO is a leading Contract Research Organisation specialising in in vitro diagnostics (IVDs) and medical devices, headquartered in Europe. We offer a comprehensive range of services, including regulatory consulting, clinical research, and quality assurance, helping clients navigate the complexities of bringing their products to market in full compliance with global regulatory standards.

At MDx CRO, we offer a dynamic and collaborative work environment within a rapidly growing company recognised across the Med
Tech and IVD industry. We are committed to fostering professional development and offering our employees opportunities for career growth and personal advancement.

We operate on five core principles:

• Make it POSSIBLE
• Make it WIN-WIN
• Keep IMPROVING
• Keep GROWING
• Keep it DIVERSE

To democratise access to
- class regulatory and clinical strategies, ensuring safer and more effective medical technologies for all.

We are pioneers of emerging technologies, navigating uncharted territories to redefine the future of the medical sector.

Grow with Us!