Clinical Development Biostatistician
hace 2 días
About this role
We are seeking a talented Clinical Development Biostatistician to join our team at Ferrer. As a key member of our Clinical Development department, you will play a vital role in ensuring the rigorous scientific integrity of our clinical trials.
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 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, programing, 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.
- Contribute to strategic planning to ensure optimized Clinical Development Plans.
- Participate in interactions with regulatory agencies, as required.
Requirements
- PhD degree in Statistics, Biostatistics, or related field with relevant academic experience, or a Master's degree in Statistics or Biostatistics 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, and proficiency in Microsoft Word and Excel.
About Ferrer
Ferrer is a global pharmaceutical company dedicated to making a positive impact in society through our purpose-driven approach. We are a group of people who believe in the power of purpose and strive to create a sustainable planet, equal opportunities for all, and a healthy workplace.
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