Senior Biostatistician

Job Summary

Key Responsibilities

• Lead statistical activities for assigned clinical studies or programs, including study design, sample size estimation, randomization, and analysis planning
• Develop, review, and finalize key statistical documents including Statistical Analysis Plans (SAPs), protocols (statistical sections), mock tables, listings, and figures (TLFs)
• Provide statistical input to clinical development plans and contribute to overall project strategy
• Ensure consistency, efficiency, and scientific rigor in statistical approaches across assigned studies
• Oversee and/or perform statistical analyses of clinical trial data across phases (Phase I–IV)
• Review and validate statistical outputs, tables, listings, and figures to ensure accuracy and interpretability
• Contribute to the preparation, review, and finalization of Clinical Study Reports (CSRs)
• Support integrated analyses, pooled analyses, and exploratory analyses as required
• Provide statistical input and responses for regulatory submissions, health authority questions, and audits
• Ensure biostatistics activities comply with corporate SOPs, ICH-GCP, and applicable regulatory guidelines (FDA, EMA, and other global agencies)
• Support inspections and internal audits by providing statistical documentation and explanations
• Work closely with Clinical Development, Data Management, Programming, Medical Writing, and Regulatory Affairs teams
• Communicate statistical concepts and results clearly to non-statistical stakeholders
• Participate in project team meetings and contribute to decision-making based on data-driven insights
• Provide technical review and quality oversight of statistical deliverables prepared by team members
• Contribute to the development and adoption of standard statistical methodologies and processes
• Ensure timely, high-quality delivery of statistical deliverables according to project timelines
• Adhere to and help improve internal SOPs, work instructions, and statistical standards
• Identify risks related to data quality or analysis and proactively propose mitigation strategies
• Mentor and guide junior and mid-level biostatisticians on project work, statistical methods, and best practices
  

Qualifications & Experience

Education

• PhD/M.Sc. in Biostatistics, Statistics, or equivalent with 6+ years of relevant industry experience
  

Experience & Skills

• Strong understanding of statistical principles and clinical trial methodology
• Hands-on experience across multiple clinical trial phases and therapeutic areas
• Solid experience contributing to regulatory submissions and interacting with regulatory agencies
• Proficiency in statistical software such as SAS (and/or R), phoenix winNonlin and SPSS.
• Knowledge of CDISC standards (SDTM, ADaM) and their application in clinical trials
• Ability to independently lead studies and manage multiple priorities
  

Competencies

• Strong analytical and problem-solving skills
• Effective written and verbal communication skills
• Ability to mentor and provide technical leadership without direct line management responsibility
• Collaborative mindset with the ability to work effectively in cross-functional teams
• High attention to detail with a strong commitment to quality and compliance