Clinical Development Biostatistician
hace 2 meses
We are seeking a highly skilled Biostatistician to join our Clinical Development team at Ferrer. As a key member of our team, you will play a crucial role in the development and implementation of clinical trials.
Responsibilities- Provide statistical input into clinical development plans and protocol development, ensuring compliance with ICH/GCP requirements and industry standards.
- Coordinate with cross-functional teams, including Project Management, Clinical Development, and Data Management, 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, ensuring accuracy and quality.
- Analyze clinical trial data, producing accurate results and validating statistical output.
- Interpret statistical results and concepts, providing clear and concise recommendations.
- Collaborate with medical writers and clinical development leads to co-author final integrated reports of clinical trial data.
- Contribute to the development of statistical standard operating procedures (SOPs) and general standardization efforts within the department.
- Participate in interactions with regulatory agencies, as required.
- PhD degree in Statistics, Biostatistics, or a related field, or a Master's degree with a minimum of 10 years of industry experience.
- Comprehensive understanding of ICH/GCP requirements, concepts, industry practice, and standards.
- International experience and 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.
- SAS proficiency, including BASE and STAT, and proficiency in Microsoft Word and Excel.
Ferrer is a global company committed to making a positive impact in society. We believe in the power of purpose and strive to bring about change in an unjust world. Our team is passionate about creating a sustainable planet, equal opportunities for all, and a healthy workplace.
We offer a flexible working model, collaborative office experience, and opportunities for development and learning. Our benefits package includes a range of perks to support your physical, emotional, and financial wellbeing.
At Ferrer, 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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