Clinical Development Biostatistician

hace 4 semanas

Barcelona, Barcelona, España Ferrer A tiempo completo
About Ferrer

Ferrer is a company that believes in the power of purpose. Our purpose is to make a positive impact in society and bring about change in an unjust world. We are a group of people who are passionate about creating a sustainable planet, equal opportunities for all, and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

Job Description

We are seeking a highly skilled Clinical Development Biostatistician to join our team. As a Clinical Development Biostatistician, you will provide statistical input into clinical development plans and protocol development. You will also coordinate closely with Project management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, and Regulatory to ensure operational excellence.

Responsibilities
  • Provides statistical input into clinical development plans and protocol development.
  • Coordinates closely with Project management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, and Regulatory.
  • Communicates with vendors regarding the development and conduct of study protocols or statistical analysis plans.
  • Reviews and provides oversight for outsourced statistical activities.
  • Analyzes clinical trial data producing accurate results.
  • Validates statistical output.
  • Accurately interprets statistical results and concepts.
  • Co-authors final integrated reports of clinical trial data.
  • Provides input into statistical standard operating procedures.
  • Participates in interactions with regulatory agencies.
  • Contributes to strategic planning to ensure optimized Clinical Development Plans.
Requirements
  • 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.
  • Must have a comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
  • Must have international experience.
  • Must have a working knowledge of data management and pharmacovigilance.
  • Excellent written and oral communication skills.
  • Experience in RWE and Late phase studies statistical participation is preferable.
  • SAS proficiency including BASE and STAT; GRAPH preferred.
  • Proficiency in Microsoft Word and Excel.
  • Strong level of detail orientation.
  • Ability to work on multiple tasks and projects under tight timelines.
Why Ferrer?
  • Make a positive impact in society.
  • Participate in volunteering activities.
  • Grow in a culture of trust, responsibility, and constructive feedback.
  • Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking.
  • Make a real difference to the team and to yourself.
  • Take advantage of opportunities for development & learning.
  • Discover a range of benefits to support your physical, emotional, and financial wellbeing.
  • Customize your remuneration and benefit.
About the Role

This is a challenging and rewarding role that requires a high level of expertise in biostatistics and clinical development. If you are passionate about making a positive impact in society and have the skills and experience to succeed in this role, we encourage you to apply.

We guarantee equal treatment and opportunities in recruitment, avoiding prejudices and stereotypes for any reason in the processes of access to the company, assessing only objective criteria such as professional and academic skills and work experience.

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