Localization Operations Specialist ensuring smooth localization operations at envelio. Collaborating with external language service providers for multilingual updates and improvements.
About the role
- Biostatistics Lead guiding statistical strategy for clinical development at Sanofi. Overseeing data integrity and analytics in pharmaceutical research with a focus on innovative treatments.
Responsibilities
- 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: perform 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.
Requirements
- 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.
- Highly effective communication in English, both oral and written.
Benefits
- Equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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