Statistical Analyst for Clinical Trials and Development

hace 1 semana

Barcelona, Barcelona, España Ferrer A tiempo completo
About the Role

We are seeking a highly skilled Clinical Development Biostatistician to join our team at Ferrer. As a key member of our Clinical Development department, you will play a critical role in the design, execution, and analysis of clinical trials.

Key Responsibilities
  1. Statistical Input and Protocol Development: Provide statistical input into clinical development plans and protocol development, including trial design, sample size estimation, randomization, and statistical methods for analysis.
  2. Collaboration and Communication: Coordinate closely with Project Management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, and Regulatory teams to ensure operational excellence.
  3. Vendor Management: Communicate with vendors regarding the development and conduct of study protocols or statistical analysis plans.
  4. Statistical Oversight: Review and provide oversight for outsourced statistical activities, including analysis plans, data review, programming, and tables and figures specifications.
  5. Data Analysis and Interpretation: Analyze clinical trial data, producing accurate results representing the outcome of the trial, and validate statistical output.
  6. Reporting and Documentation: Co-author final integrated reports of clinical trial data, securing thorough and clear statistical methods sections and the statistical appendix for the final report.
  7. Process Improvement: Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department.
  8. Regulatory Interactions: Participate in interactions with regulatory agencies, as required.
  9. Strategic Planning: Contribute to strategic planning to ensure optimized Clinical Development Plans.
Requirements
  1. Education and Experience: PhD degree in Statistics, Biostatistics, or related field with relevant academic experience, or a Master's degree in Statistics or Biostatistics or a related field and a minimum of 10 years of industry experience.
  2. ICH/GCP Requirements: Must have a comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
  3. International Experience: Must have international experience.
  4. Data Management and Pharmacovigilance: Must have a working knowledge of data management and pharmacovigilance.
  5. Communication Skills: Excellent written and oral communication skills, including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials.
  6. Technical Skills: SAS proficiency, including BASE and STAT; GRAPH preferred, and proficiency in Microsoft Word and Excel.
  7. Attention to Detail: Strong level of detail orientation.
  8. Time Management: Ability to work on multiple tasks and projects under tight timelines.
  9. Travel Requirements: Travel required (5-10%).

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