Homeoffice Biostatistician & SAS programmer with verification

Department Info

The European Medical and Clinical Division (EMCD) supports the generation and analysis of clinical data to demonstrate the benefits of our products, collaborating with physicians to publish findings that enhance patient care. EMCD also plays a key role in new product development and works closely with Regulatory, Marketing, and Sales to provide medical expertise and leverage clinical data.

The Biometrics team manages data collection, programming, and biostatistics, ensuring high-quality data from design to dissemination. Focusing on data collection, reliable statistical results, standardization, and compliance to effectively assess the risk-benefit profile of our products.

Job Summary

We are looking for an experienced Biostatistician & SAS Programmer to join our Biometrics team at the European Medical and Clinical Division (EMCD). Reporting to the Biometrics Manager, you will collaborate closely with clinical and medical teams to provide statistical and analytical results and expertise for clinical trials. This role involves close collaboration with Data-management, statistical expertise and SAS programming skills while ensuring compliance with regulatory standards. If you're excited to contribute to high-quality clinical research and work in a innovative and dynamic environment, we encourage you to apply.

Job Responsibilities

As a Biostatistician & SAS Programmer, your key responsibilities will include:

1. General Statistics Consultancy:

• Collaborate with EMCD Clinical and Medical teams across therapeutic areas, and globally with other Terumo entities when required.
• Work closely with the Data Management and Programming teams to ensure data integrity and support quality assurance.
• Maintain advanced competence in statistical analysis, trial design, and innovative methods such as AI, to ensure state-of-the-art approaches are used.
• Provide biostatistical expertise in multidisciplinary teams responsible for clinical trials, including oversight of biometrics activities performed by external vendors or CROs.
• Ensure all statistical deliverables are completed within timelines and meet scientific, regulatory, and quality requirements.
• Provide training on statistical concepts to non-statisticians when necessary.

2. Statistical Input to Study Design:

• Define and review study designs, methodologies, primary/secondary endpoints, and sample size calculations for clinical trials.
• Support the clinical investigation plan (CIP) and respond to regulatory questions related to statistical analyses.

3. Data Management Support:

• Review key data management documents like the Functional Requirement Specifications (FRS) and Case Report Forms (CRF).
• Participate in User Acceptance Testing (UAT) and ensure statistical oversight for primary and secondary endpoints.
• Contribute statistical perspectives to the Data Management Plan (DMP) and Data Review Guidelines.

4. Statistical Programming:

• Write, review, and approve the Statistical Analysis Plan (SAP), including the creation of Tables, Figures, and Listings (TFL) mock shells and specification files.
• Develop and optimize SAS programs to generate analysis datasets (ADaM) and automate statistical results, ensuring compliance with internal standards.
• Develop, update, and troubleshoot SAS Macros to streamline workflows.
• Support clinical and medical teams in interpreting and presenting statistical results.

5. Quality Assurance:

• Ensure full traceability and transparency throughout the data process, from study design to final data dissemination.
• Identify opportunities for improving statistical and programming procedures to maintain high standards of data quality and compliance.

6. Innovation & Continuous Improvement:

• Identify and implement new statistical methods and tools.
• Contribute to data visualization using advanced techniques like R or PowerBI.

7. General Contributions:

• Represent the company and promote core values in all professional activities.
• Take on additional responsibilities and opportunities as they arise, contributing to new initiatives where necessary.

Profile description

Education: Degree in Biostatistics, Mathematics, or related field.

Experience: Minimum 3-4 years in statistics and clinical research, preferably in the medical device, CRO, pharmaceutical, or biotech sectors.

Technical Skills:

• Proficiency in SAS programming (CDISC, TFL, Macros).
• Experience in R and/or Python; familiarity with PowerBI is a plus.

Soft Skills:

• Excellent collaboration, communication, and presentation skills.
• Ability to work both autonomously and within a multicultural matrix organization.

Compliance & Attention to Detail: Knowledge of data protection regulations, GCP, and ICH guidelines.

Languages: Fluent in English (additional European language is a plus).

Travel Flexibility: Open to travel up to 10% (Leuven HQ and industry congresses).

We offer

At Terumo, we offer more than just a job – it’s a chance to make a meaningful impact and be part of a passionate, high-performing team.

• Competitive Rewards: We provide a salary and benefits package that recognizes your dedication.
• Inclusive Team Environment: Join a respectful and inclusive team that values diversity and equality.
• Growth Opportunities: We invest in your personal and professional development through various learning opportunities.
• Work-Life Balance: Enjoy flexible hybrid working, with remote work options and a maximum of 10% travel for this role.
• Connect with Us: Engage with our team and hiring manager throughout the recruitment process.