Overview
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.
Responsibilities
* Reviewing and approving all biostatistics documentation and statistical programming outputs, overseeing project budgets and timelines, and ensuring overall quality and consistency across assigned accounts.
* Contributes to talent acquisition efforts and collaborates with Quality Management to establish and maintain standard operating procedures (SOPs) and training programs.
* 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.
Qualifications
* Master's degree in Statistics, Biostatistics, or a related quantitative field is required with 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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