Related skills
ads sas biostatistics clinical trials regulatoryπ Description
- Lead statistical activities for clinical studies (Immunology/therapeutic areas)
- Independently manage statistical strategy and deliverables
- Collaborate with Clinical, Programming, Data Management, Regulatory
- Guide statistical programmers and oversee deliverables
- Communicate statistical concepts and results clearly to stakeholders
- Ensure compliance with FDA, ICH, GCP and SOPs
π― Requirements
- MS or PhD in Statistics, Biostatistics, or related field
- Strong Immunology/therapeutic-area clinical study experience
- Hands-on SAS programming; SAS SAPs
- Experience with Analysis Database Specifications (ADS)
- Experience leading Phase IIβIII trials
- CRO/pharma industry experience; regulatory interactions
- Excellent written and verbal communication
- Mentoring junior statisticians or programmers
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