Director of Biostatistics and Clinical Research
2 weeks ago
About Genmab: As a leader in the biotechnology industry, we are committed to discovering and developing innovative treatments for cancer and other life-threatening diseases. Our goal is to make a meaningful impact on the lives of patients and their families.
We value a collaborative and inclusive work environment that fosters creativity, innovation, and scientific excellence. Our team is passionate about advancing the field of biotechnology and improving patient outcomes.
Job Summary:The Director of Biostatistics and Clinical Research will oversee the development and implementation of clinical trial designs and statistical methodologies for our pipeline of compounds. This key role will collaborate with cross-functional teams to ensure timely and efficient clinical trial execution while maintaining compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement clinical trial designs and statistical methodologies
- Lead statistical analysis and modeling for designated compounds/indications
- Collaborate with cross-functional teams to ensure timely and efficient clinical trial execution
- Ensure compliance with regulatory requirements, including ICH-GCP and FDA/EMA guidance
- Masters or PhD in a statistical discipline with 12+ years of experience in relevant technical areas
- Proven track record of success in directing complex clinical trials and biostatistical projects
- Experience working with regulatory authorities, including FDA and EMA
- Strong leadership and communication skills
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