More specifically, the Senior Statistical Advisor must:

• Provide strategic statistical input into clinical development plans, trial protocols, and other research projects, recommending scientifically rigorous, efficient, and cost-effective designs and appropriate statistical methods.
• Develop SAPs for complex studies and provide peer review for SAPs and TLF Shells for clinical trials.
• Resolve complex statistical issues and provide scientifically sound, practical recommendations.
• Interpret clinical trial results and communicate statistical concepts, findings, and their implications clearly to technical and non-technical audiences to inform decision-making.
• Provide statistical expertise for regulatory submissions, agency interactions, and responses to regulatory queries, in collaboration with sponsors and cross-functional teams.
• Contribute to the development of abstracts, manuscripts for peer-reviewed publication, posters, and scientific presentations.
• Provide scientific mentoring and training to biostatisticians and statistical programmers to strengthen methodological expertise and statistical judgment and ensure alignment with applicable ICH guidelines, regulatory requirements, and company standards.
• Serve as an independent unblinded biostatistician supporting IDMC reviews and/or interim analyses, as appropriate, in accordance with applicable charters, analysis plans, and blinding procedures.
• Maintain current knowledge of statistical methodologies, industry standards, and regulatory guidance, and assess their implications for statistical practice.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they havE the required experience, are qualified and/or have received adequate training.