Senior Manager, Biostatistics F/M

Ipsen Pharma; London; Remote; GBP 70,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Manager of Biostatistics to provide statistical support for clinical development. This role involves strategic contributions to project decisions, ensuring regulatory compliance, and collaborating with various teams. Ideal candidates will have extensive experience in clinical biostatistics and a strong background in statistical methods.

Qualifications

• Minimum of a Master's degree and 15 years of relevant industry experience.
• Experience in rare disease clinical development and regulatory submissions.
• Proficiency in SAS and R programming for data management and analysis.

Responsibilities

• Provide statistical support and contribute to project decisions.
• Implement advanced statistical methodologies for clinical trials.
• Collaborate with multidisciplinary teams and drive regulatory submissions.

Skills

Statistical theory

SAS programming

R programming

Leadership

Communication

Education

Master's degree

Ph.D. preferred

Tools

MS Word

Excel

PowerPoint

Job description

Title:

Senior Manager, Biostatistics F/M

Company:

Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease, and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France, and the U.K., we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact. At Ipsen, every individual is empowered to be their true selves, grow, and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Purpose of the position

The Senior Manager of Biostatistics is responsible for providing broad statistical support and contributing strategically to project decisions, focusing on clinical planning, study design, protocol development, sample size/power calculations, simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table/listing/figure templates, programming and production, oversight of contract or CRO resources, and preparation, integration, and documentation of clinical regulatory submission packages, in accordance with CDISC standards. This role is expected to act independently as the statistical subject matter expert for all clinical development programs and studies, ensuring adherence to all regulatory requirements.

Responsibilities

• Deep understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data, and multiplicity handling.
• Ability to implement state-of-the-art statistical methodologies for clinical trial design, execution, and evaluation.
• Effective collaboration with multidisciplinary teams including clinicians, clinical operations, medical writing, regulatory affairs, IT, and external partners.
• Engagement in discussions with key opinion leaders regarding clinical study design and evaluation from a statistical perspective.
• Making well-justified decisions in ambiguous situations, prioritizing tasks, and leading teams accordingly.
• Driving submissions and ensuring high-quality regulatory documentation.

Knowledge & Experience:

• Experience in rare disease clinical development and regulatory submissions.
• Strong knowledge of statistical theory and methods.
• Proficiency in SAS and R programming for data management, analysis, and visualization.
• Excellent communication, leadership, and intercultural skills.
• Self-management with initiative-taking and strategic thinking abilities.
• Proficiency in MS Word, Excel, PowerPoint.
• Understanding of clinical and statistical regulatory standards (GCP, ICH, CDISC).
• Minimum of a Master's degree and 15 years of relevant industry experience; Ph.D. preferred with at least 8 years in clinical biostatistics within pharma, biotech, or medical devices.

Language: English

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Dans le cadre de ses recrutements, IPSEN s'engage au respect de l'égalité de traitement des candidats, indépendamment du sexe, de l'âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.