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Lead Biostatistician

Lead Biostatistician

Mantell Associates, , Spain, España
Hace 2 días
Descripción del trabajo

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Mantell Associates is partnered with a leading pharmaceutical company dedicated to advancing oncology research, who is seeking an experienced Lead Biostatistician to support a pivotal Phase IV clinical trial in oncology.

This is a contract position offering immediate start, full-time engagement, and the opportunity to shape statistical and analytical strategy in a high-impact post-marketing study.

Responsibilities

  • Serve as the statistical lead for the oncology Phase IV trial, providing expert input into study design, protocol development, and statistical analysis plans (SAPs)
  • Oversee data analysis activities, ensuring accuracy, reproducibility, and compliance with regulatory and study-specific standards
  • Collaborate closely with Clinical Science, Data Management, Programming, and Medical Affairs to ensure data integrity and scientific robustness
  • Develop and validate statistical methodologies for safety, efficacy, and exploratory endpoints, including real-world evidence (RWE) and post-approval data analysis
  • Conduct statistical reviews of deliverables, interpret results, and contribute to clinical study reports, publications, and regulatory submissions
  • Support data visualization, interim analyses, and strategic decision-making through strong analytical insight and communication of findings to non-statistical audiences
  • Mentor junior statisticians and coordinate statistical activities with CRO partners or external collaborators

Qualifications

  • Master’s or PhD in Statistics, Biostatistics, or a related quantitative discipline
  • Strong biostatistics experience within the pharmaceutical or CRO industry, including proven leadership of statistical components in clinical trials
  • Strong hands-on expertise in oncology studies - Phase III or IV experience preferred
  • Proficiency with SAS and / or R, with strong understanding of CDISC standards (SDTM, ADaM) and ICH-GCP guidelines
  • Experience with real-world data (RWD) and post-marketing surveillance analyses advantageous
  • Excellent communication and cross-functional collaboration skills, with the ability to translate statistical results into actionable insights
  • Fluent in English; French language proficiency is highly desirable
  • Based in Europe with eligibility to work; fully remote candidates within the EU are welcome
  • Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) .

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