Senior Manager, Biostatistics F/M

Ipsen Innovation (SAS); Boulogne; À distance; EUR 80 000 - 110 000; Plein temps

Résumé du poste

An established industry player is seeking a Senior Manager of Biostatistics to provide strategic support across clinical development programs. This role involves designing innovative statistical methodologies, collaborating with diverse teams, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in rare disease development, a strong command of statistical theory, and proficiency in SAS and R programming. Join a forward-thinking company dedicated to transforming lives through biopharmaceutical innovation and make a significant impact in the field.

Qualifications

• Master's degree with 15+ years of industry experience.
• Experience in rare disease development and regulatory submissions.

Responsabilités

• Design and implement statistical methodologies for clinical trials.
• Collaborate with multidisciplinary teams and external partners.

Connaissances

Statistical Theory

SAS Programming

R Programming

Communication Skills

Leadership Skills

Problem-Solving

Formation

Master's Degree

Ph.D. in Biostatistics or Statistics

Outils

MS Office

Description du poste

Here is a refined version of the job description for better clarity, formatting, and focus:

Senior Manager, Biostatistics F/M

Apply at London | Type: Full time | Posted: 21 Days Ago | Requisition ID: R-18625

Company Overview

Ipsen Innovation (SAS) is a mid-sized global biopharmaceutical company dedicated to transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of development experience and hubs in the U.S., France, and the U.K., we focus on high unmet medical needs through research and innovation.

Our teams in over 40 countries are committed to delivering medicines to patients in 88 countries. We foster a culture of human-centric leadership, collaboration, excellence, and impact, empowering individuals to grow and thrive. Join us in our journey towards sustainable growth and societal impact.

Job Description

Purpose of the Position

The Senior Manager of Biostatistics provides strategic statistical support across clinical development programs. Responsibilities include study design, protocol development, sample size calculations, statistical analysis, data quality review, and regulatory documentation, ensuring compliance with CDISC standards. Acts as the subject matter expert, ensuring adherence to regulatory requirements.

Responsibilities

• Design and implement innovative statistical methodologies for clinical trials.
• Collaborate effectively with multidisciplinary teams and external partners.
• Engage with key opinion leaders on study design and evaluation.
• Make informed decisions in ambiguous situations, prioritize tasks, and lead teams.
• Drive clinical submissions and regulatory documentation.

Knowledge & Experience

• Experience in rare disease development and regulatory submissions.
• Strong knowledge of statistical theory, SAS, and R programming.
• Excellent communication, leadership, and intercultural skills.
• Proficiency in MS Office and problem-solving abilities.
• Understanding of GCP, ICH, CDISC regulations.

Qualifications

• Master's degree with at least 15 years of industry experience.
• Preferred: Ph.D. in Biostatistics or Statistics with 8+ years of relevant experience.

Languages: English

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At Ipsen, we are committed to equal opportunity employment, respecting diversity and inclusion in our recruitment process.

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