Principal Statistician Oncology with Submission Experience
Position Overview: Responsible for statistical oversight and support across all phases of oncology clinical trials, from protocol development through submission and reporting.
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians, and develop training plans.
Direct other biostatistics personnel on projects, ensuring timely, high‑quality work.
Support all statistical tasks during the project lifecycle, from protocol to CSR.
Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures.
Lead biostatistician for protocol design, randomization schedule, and input to the clinical study report.
Create or review programming specifications for datasets, tables, listings, and figures.
Review CRFs, database design, and other documentation to ensure protocol criteria are met.
Implement company objectives and develop alternative solutions to address business and operational challenges.
Act as the biostatistics representative on project teams and interface with other departmental representatives.
Prepare for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
Verify and conduct quality control of project deliverables, ensuring outputs meet SAP and specifications.
Lead complex or multiple projects (e.g., submissions, integrated analyses), attend regulatory agency meetings or respond to questions to support statistical results of clinical trials.
Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and communicate difficulties with meeting timelines.
Monitor progress on study activities against milestones and ensure deliverables are met; identify out‑of‑scope tasks and report to management.
Provide statistical programming support as needed.
Participate in DSMB and/or DMC activities, including charter development and serving as an independent or voting biostatistician.
Follow SOPs, work instructions, and regulatory guidelines (e.g., ICH).
Maintain organized, complete, and up‑to‑date project documentation and QC documents to ensure inspection readiness.
Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Perform other work‑related duties as assigned.
Minimal travel may be required.
Qualification Requirements
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials (or equivalent education and experience) demonstrating ability to lead multiple projects and programs.
Proficiency in programming.
Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques, and to communicate statistical concepts effectively.
Experience supporting all statistical tasks during the project lifecycle, from protocol to CSR.
Experience with regulatory submissions is preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Summary
Oncology experience is required. PhD/MS in statistics or related discipline with 6‑8 years of pharmaceutical experience. Broad knowledge and good understanding of advanced statistical concepts and techniques, with ability to conduct advanced analyses using SAS or R.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, and complies with the EU Equality Directive and related legislation.
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