Main responsibilities include:
Lead statistical strategy and drive clinical development plans during translation, the clinical study designs for early development; determine optimal sample sizes and randomization approaches;
Oversee statistical analyses & deliverables: manage statistical analysis plans, ensure delivery of high-quality statistical reports and documentation, review and validate statistical content in protocols and study reports
Conduct advanced analytics: preform exploratory and ad-hoc analyses using R, SAS, JMP, and other statistical tools; analyze clinical and non-clinical data and prepare statistical reports; support data interpretation for publications
Maintain statistical integrity according to regulatory guidelines; adhere to SOPs and internal standards; contribute to process optimization and quality standards
Partner with study teams and senior leadership; represent statistics in cross-functional initiatives; participate in scientific working groups
Plan and track statistical activities; coordinate with Global Head of Biostatistics Translational Medicine & Research; define team priorities and goals
Conduct team performance reviews, develop training plans for junior staff, and promote innovation and operational efficiency
3. About you
8+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experiences. Experience of project/with people management and development preferred.
Demonstrated strong project/study management, interpersonal and communication skills.
Broad knowledge and good understanding of advanced statistical concepts and techniques
Good knowledge of early and late pharmaceutical clinical development & research
Extensive ability to apply advanced statistical analyses using SAS and R languages.
Knowledge or experience with Artificial intelligence or Generative AI is a plus
Education: MS or PhD degree in Statistics, Biostatistics, Bioinformatics or relevant fields
Languages: Highly effective communication in English, both oral and written