Lead Biostatistician – Statistical Programming

Job title:

Lead Biostatistician – Statistical Programming

Company:

Oracle

Job description

Job Category: ConsultingJob Description: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.Responsibilities:What you will do:

• 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.

Requirements:Education

• 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.

Experience

• 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

Skills

• 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

Qualifications:Career Level – IC4About Us:As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all.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.We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 888 404 2494 in the United States.Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

Expected salary

Location

España

Job date

Fri, 01 Aug 2025 03:38:45 GMT

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