Senior Biostatistician - R&D Trial Design (Remote)

MiniMed Group; Madrid; Remote; EUR 60,000 - 85,000; Full time

Job summary

MiniMed in Madrid is seeking a Senior Statistician to lead biostatistical components for R&D programs, supervising the design and execution of studies, and ensuring safety, efficacy, and marketability of products.

You will develop statistics plans, contribute to trial designs, and collaborate with clinicians and programmers, while aligning with health authority guidelines and regulatory expectations.

Qualifications

• Advanced knowledge of the field combining breadth and depth.
• Practical knowledge of project management.
• A Baccalaureate degree and minimum of 4 years relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities

• Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
• Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
• In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Develops and/or applies statistical theories, methods, and software.
• Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
• Provides specifications and directions to the clinicians/statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Skills

Biostatistics

Clinical trial methodology

Statistical analysis

Project management

Education

Bachelor's or equivalent degree in a relevant field

Advanced degree (MS/PhD) preferred

Tools

SAS

R

Job description

MiniMed in Madrid is seeking a Senior Statistician to lead biostatistical components for R&D programs, supervising the design and execution of studies, and ensuring safety, efficacy, and marketability of products.

You will develop statistics plans, contribute to trial designs, and collaborate with clinicians and programmers, while aligning with health authority guidelines and regulatory expectations.