Senior Statistical Scientist

hace 4 semanas

Madrid, Madrid, España Ergomed A tiempo completo
Position Overview

The Senior Statistical Scientist plays a pivotal role in the design, evaluation, and interpretation of clinical research as a primary contributor or team member for various clinical trials.

In this capacity, the statistical scientist collaborates with a diverse team, including sponsors, project managers, clinical personnel, data analysts, medical writers, statistical programmers, and other stakeholders to fulfill the statistical requirements of assigned clinical projects.

Responsibilities include the creation, assessment, maintenance, and supervision of all statistical outputs and activities as per contractual obligations. Key tasks may encompass, but are not limited to, relevant sections of clinical protocols, statistical analysis plans, data and safety review meetings, content development specifications, and contributions to summary reports.

  • Act as the lead statistician for multiple clinical trials, programs, integrations, submissions, adaptive designs, and other intricate studies.
  • Review and oversee statistical outputs generated by other members of the statistical team.
  • Provide expert consultation to sponsors and internal teams on study design, exploratory analyses, statistical methodologies, and other pertinent subjects.
  • Represent sponsors during regulatory discussions.
  • Present significant statistical findings to Safety Review Committees and similar entities.
  • Participate in qualification audits, study audits, and other pre-trial evaluation activities.
  • Engage in bid defenses and other sales-related initiatives, including reviewing RFP content, contributing to budget discussions, and offering insights on study design.
  • Lead initiatives aimed at process enhancements on behalf of management.
  • Support the head of Biostatistics and, when necessary, the Head of Biometrics on statistical issues, process improvements, industry trends, and other relevant matters.
Required Qualifications

Education

A Bachelor's Degree in a relevant field such as Computer Science, Mathematics/Statistics, or a quantitative natural science is preferred.

  • Comprehensive knowledge of SAS programming and statistical programming concepts pertinent to clinical trials, including statistical analysis procedures and/or indication-specific methodologies; expertise in one or more areas is advantageous.
  • Advanced understanding of CDISC standards.

Experience

A minimum of 8 years of relevant experience or an equivalent combination of skills and education is required.

Essential Skills

  • Strong organizational abilities, with a keen attention to detail and the capacity to manage multiple tasks.
  • Excellent communication skills.

Technical Skills

Proficiency in the MS Office Suite is expected.

Expertise in one or more statistical programming languages, including SAS, is essential.

Additional Insights

Ergomed is committed to fostering diversity, equity, and inclusion by cultivating an equal opportunity workplace and a human-centric environment where individuals from all cultural backgrounds, genders, and ages can thrive and develop.

Our success hinges on collaboration with a human-first approach, recognizing that our people are our greatest asset, driving our ongoing mission to enhance the lives of those around us.

We provide:

  • Opportunities for training and career advancement within the organization.
  • A strong focus on personal and professional development.
  • A friendly and supportive work atmosphere.
  • The chance to collaborate with colleagues globally, with English as the primary language of communication.

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