The Lead Biostatistician builds and maintains trusted advisor relationships with clients and internal teams, focusing on delivering client value and fostering long-term growth. They are responsible for developing and leading high-performing project teams, ensuring all work is conducted in compliance with internal SOPs, ICH guidelines, industry standards, and regulatory requirements.
Key responsibilities include reviewing and approving all biostatistics documentation and statistical programming outputs, overseeing project budgets and timelines, and ensuring overall quality and consistency across assigned accounts.
In addition, the Lead Biostatistician contributes to talent acquisition efforts and collaborates with Quality Management to establish and maintain standard operating procedures (SOPs) and training programs. They provide advanced statistical expertise in the planning and design of clinical trials and non-interventional studies (NIS), perform in-depth data analyses, and offer statistical guidance for study reporting.
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.
Provide expert statistical input to study documents, including Case Report Forms (CRFs), Data Management Plans (DMPs), and clinical protocols.
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.
Foster and maintain trusted relationships with clients, leading communication on statistical matters and contributing to long-term collaboration.
Mentor junior team members, contribute to training initiatives, and promote a high-performing, quality-focused team culture.
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.
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.
Excellent communication skills (written and verbal) in English.
Excellent skills and knowledge of MS Office and IT
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