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, analysis, and interpretation of clinical research as a lead or contributing member of various clinical projects.

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

The responsibilities of the statistical scientist encompass the creation, review, maintenance, and oversight of all statistical outputs and activities. These duties may include, 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 studies, programs, integrations, submissions, adaptive designs, and other intricate projects.
  • Provide oversight and review of statistical outputs generated by other members of the biostatistics team.
  • Offer consultative support to sponsors and internal teams on study design, exploratory analyses, statistical methodologies, and other pertinent topics.
  • Represent sponsors in regulatory discussions.
  • Present significant statistical findings to Safety Review Committees and similar entities.
  • Participate in qualification audits, study audits, and other pre-trial assessment activities.
  • Engage in bid defenses and other sales-related activities, including reviewing RFP content, contributing to budget discussions, and providing insights on study design.
  • Lead initiatives and process enhancement activities on behalf of management.
  • Support the head of Biostatistics and, as necessary, the Head of Biometrics on statistical issues, process improvements, industry trends, and other relevant matters.
Qualifications

Education:

A Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science.

  • Comprehensive knowledge of SAS programming and statistical programming topics relevant to clinical trials, including statistical analysis procedures and/or indication-specific methods; may possess expertise in one or more areas.
  • Advanced understanding of CDISC standards.

Experience:

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

Special Skills:

  • Strong organizational skills, with a keen attention to detail and the ability to multitask.
  • Excellent communication skills.

Technical Skills:

Proficient in the MS Office Suite and one or more statistical programming languages, including SAS.

Additional Information

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

To achieve success, we believe in a collaborative approach. Our people are our greatest asset, driving our ongoing commitment to enhancing the lives of those around us.

We offer:

  • Opportunities for training and career development.
  • A strong focus on personal and professional growth.
  • A friendly and supportive work environment.
  • The chance to collaborate with colleagues globally, with English as the primary language.

Our core values guide our operations, and if they resonate with you, Ergomed could be the ideal place for you.

Core Values:

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

We look forward to receiving your application.

#LI Remote



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