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Biostatistician for Clinical Development and Research
hace 2 meses
About the Role
Ferrer is seeking a highly skilled Clinical Development Biostatistician to join our team. As a key member of our Clinical Development department, you will play a critical role in the design, analysis, and interpretation of clinical trials.
Key Responsibilities
- Provide statistical input into clinical development plans and protocol development, including trial design, sample size estimation, randomization, and statistical methods for analysis.
- Coordinate closely with cross-functional teams, including Project Management, Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Legal, Finance, and Regulatory to ensure operational excellence.
- Communicate with vendors regarding the development and conduct of study protocols or statistical analysis plans.
- Review and provide oversight for outsourced statistical activities, including analysis plans, data review, programming, and tables and figures specifications.
- Analyze clinical trial data, producing accurate results representing the outcome of the trial, and validate statistical output.
- Accurately interpret statistical results and concepts.
- Collaborate with the medical writer, Clinical Development Lead, and Clinical Development Medical Lead to co-author final integrated reports of clinical trial data.
- Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department.
- Participate in interactions with regulatory agencies, as required.
- Contribute to strategic planning to ensure optimized Clinical Development Plans.
Requirements
- PhD degree in Statistics, Biostatistics, or a related field with relevant academic experience, or a Master's degree in Statistics or Biostatistics or a related field with a minimum of 10 years of industry experience.
- Comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
- International experience.
- Working knowledge of data management and pharmacovigilance.
- 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.
- 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.
About Ferrer
Ferrer is a global healthcare company committed to making a positive impact in society. We are a group of people who believe in the power of purpose and strive to bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all, and a healthy workplace. We reject greenwashing and empty promises - we are about action. In 2022, we became a B Corp company, founded in Barcelona in 1959, with a team of over 1,800 people. We empower professionals to become leaders of change and build meaningful careers.
