Associate Director, Biostatistics: Clinical Trials Strategy

Cytel; Cheyenne (WY); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Cytel is seeking an Associate Director of Biostatistics to dedicate their expertise to one of our FSP clients, leading and supporting clinical trials with advanced statistical methods. You will influence development plans, study concepts, and regulatory documents while overseeing external deliverables and contributing to methodological innovations.

The role requires a Master’s in Statistics with 7+ years in biotech/pharma, strong programming in R/SAS/Python, and regulatory experience with CDISC

Qualifications

• Master’s degree in Statistics or related field; 7+ years biotech/pharma experience.
• Experience with diverse statistical methods and ML/AI knowledge.
• Strong regulatory knowledge for drug development and submissions.
• Proficient in R, SAS, and Python.
• CDISC SDTM/ADaM experience and dataset submissions.
• Vendor management experience.
• Experience in Neuromuscular, Ophthalmology or related TA preferred.
• Excellent communication and attention to detail; ability to work independently.

Responsabilités

• Support statistical strategy for assigned programs, including input to development plans and protocols, SAPs, clinical study reports and publications.
• Oversee biostatistics deliverables produced by external resources.
• Provide statistics input in protocols, CSRs, and scientific presentations.
• Review randomization procedures and randomization lists.
• Review CRFs and data management plans to ensure protocol requirements are met.
• Oversee outsourced statistical CRO activities and deliverables.
• Develop innovative tools and methodologies for analysis.
• Contribute to department strategies and cross-functional initiatives.

Connaissances

Statistical analysis

Machine learning

Regulatory knowledge

Vendor management

Communication skills

Formation

Master’s degree in Statistics

PhD preferred

Outils

R

SAS

Python

Description du poste

Cytel is seeking an Associate Director of Biostatistics to dedicate their expertise to one of our FSP clients, leading and supporting clinical trials with advanced statistical methods. You will influence development plans, study concepts, and regulatory documents while overseeing external deliverables and contributing to methodological innovations.

The role requires a Master’s in Statistics with 7+ years in biotech/pharma, strong programming in R/SAS/Python, and regulatory experience with CDISC