Senior Quantitative Analyst - Biostatistics

Overview The Lead Biostatistician role is a strategic position that builds trusted advisor relationships with clients and internal teams to deliver client value and foster long-term growth.

This key role requires an individual who can review and approve biostatistics documentation, oversee project budgets and timelines, and contribute to talent acquisition efforts.

The ideal candidate will provide advanced statistical expertise in study design, perform in-depth data analyses, and offer statistical guidance for study reporting.

Responsibilities Reviewing and approving biostatistics documentation and statistical programming outputs.

Overseeing project budgets and timelines, ensuring overall quality and consistency across assigned accounts.

Contributing to talent acquisition efforts and collaborating with Quality Management to establish and maintain standard operating procedures (SOPs) and training programs.

Provide strategic statistical guidance on study design, including statistical model selection, sample size calculations, and analysis planning.

Lead the development and programming of statistical analyses, tables, figures, and listings 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 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.

Lead the statistical review and interpretation of Clinical Study Reports (CSRs).

Proactively prioritize and manage multiple studies and projects to meet timelines and client expectations.

Serve as a primary statistical point of contact for internal and external stakeholders.

Ensure all statistical deliverables meet applicable regulatory standards and industry guidelines.

Foster and maintain trusted relationships with clients and lead communication on statistical matters.

Drive the continuous improvement and development of internal statistical programming practices and guidelines.

Mentor junior team members, contribute to training initiatives, and promote a high-performing team culture.

Collaborate with cross-functional teams to deliver innovative statistical strategies that align with client objectives.

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