Overview
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.
Responsibilities
* 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.
Qualifications
* Master's degree in Statistics, Biostatistics, or a related quantitative field is required with a minimum of 5-8 years 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.
Benefits
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
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