
Lead Biostatistician for Clinical Data Analysis
il y a 2 jours
Ipsen Pharma is a leading pharmaceutical company that specializes in developing innovative treatments for rare diseases.
Job DescriptionWe are seeking a highly skilled Lead Biostatistician for Clinical Data Analysis to join our team. The successful candidate will be responsible for analyzing and interpreting clinical trial data, ensuring the quality and efficiency of biometry deliverables, and collaborating with cross-functional teams to develop regulatory submissions.
About the Role- Analyze and interpret complex clinical trial data using SAS programming language, ensuring compliance with regulatory requirements (FDA, ICH)
- Develop and maintain high-quality statistical analysis plans, datasets, and reports, adhering to CDISC specifications
- Collaborate with statisticians, programmers, and other clinical team members to perform ad-hoc analyses and generate outputs according to requirements
- Participate in operations meetings and address issues that may influence statistical programming and data management
- Work closely with CRO statisticians and review their work/deliveries, understanding clinical trial design and reporting processes, as well as regulatory reporting requirements
- Bachelor's degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or related scientific discipline required
- 5+ years of experience in biostatistics or a related field, with expertise in SAS programming language, regulatory requirements, and CDISC implementation
- Demonstrable knowledge of clinical trials, data structures, and medical dictionaries
- Excellent communication and collaboration skills, with ability to work in a fast-paced environment
- A competitive salary range: $120,000 - $180,000 per year
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off
- Opportunities for professional growth and development, with training and support for advanced certifications
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