Lead Biostatistician - Statistical Programming

• Provide strategic statistical guidance on study design, including statistical model selection, sample size calculations, and analysis planning across clinical trials and non-interventional studies (NIS).
• Lead the development and programming of statistical analyses, tables, figures, and listings (TFLs) using SAS, ensuring alignment with sponsor requirements and internal standards.
• Generate and validate derived analysis datasets in compliance with CDISC ADaM standards.
• Author, review, and ensure rigorous quality control (QC) of Statistical Analysis Plans (SAPs) and related statistical documentation.
• Validate programming output (e.g., TFLs, datasets) generated by team members to ensure accuracy and consistency.
• Provide expert statistical input to study documents, including Case Report Forms (CRFs), Data Management Plans (DMPs), and clinical protocols.
• Oversee and ensure proper execution of randomization procedures.
• Conduct and interpret meta-analyses using statistical results from multiple published studies, ensuring scientifically robust conclusions.
• Lead the statistical review and interpretation of Clinical Study Reports (CSRs), ensuring alignment with the SAP and regulatory expectations.
• Proactively prioritize and manage multiple studies and projects to meet timelines and client expectations, balancing resources and risk.
• Serve as a primary statistical point of contact for internal and external stakeholders, providing clear, compliant, and insightful responses and guidance.
• Ensure all statistical deliverables meet applicable regulatory standards (e.g., ICH, GCP), industry guidelines, and internal SOPs.
• Foster and maintain trusted relationships with clients, leading communication on statistical matters and contributing to long-term collaboration.
• Drive the continuous improvement and development of internal statistical programming practices, guidelines, and SOPs.
• Mentor junior team members, contribute to training initiatives, and promote a high-performing, quality-focused team culture.
• Serve as a domain expert, integrating clinical, statistical, and industry best practices to design tailored solutions for complex client needs.
• Collaborate with cross-functional teams to deliver innovative, high-impact statistical strategies that align with client objectives.

• Master's degree in Statistics, Biostatistics, or a related quantitative field is requiredwith a minimum of 5-8 of practical experience.
• PhD in a relevant field is highly preferred.

• Minimum 5-8 years of relevant experience in biostatistics, preferably in the pharmaceutical, CRO, or life sciences sector.
• Solid experience with non-interventional / observational studies and Phase 3 or Phase 4 clinical trials.
• Demonstrated experience working with CDISC standards (including SDTM and ADaM).
• Good knowledge of the industrial standards (CDISC, ICH E9, GCP)
• Proficiency in SAS and R programming with a minimum of 5 years of experience with both software.
• Prior experience acting as a client-facing lead statistician, including proposal support and study design.
• Strong understanding of project management, including budget management, timelines, and resource allocation.
• Experience mentoring or leading junior statisticians or project team members.
• Ability to further develop programming standards and research methods

• Excellent communication skills (written and verbal) in English.
• Ability to manage multiple studies and clients simultaneously.
• Strong organizational skills and attention to detail.
• High level of initiative, accountability, and professionalism.
• Excellent skills and knowledge of MS Office and IT
• Sound numerical reasoning
• Highly analytical with a problem-solving approach

Oracle