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Protocol Intelligence
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Job Description
Structured overview of role & requirementsAbout This Role
Prepare and review statistical analysis plans, datasets, and TLFs ensuring high quality and accuracy.
Lead statistical efforts on single studies, managing timelines, budgets, and client communication.
Mentor junior staff and participate in risk management, protocol development, and database lock/unblinding processes.
Minimum Requirements
Bachelor's, Master's, or Ph.D. in Biostatistics or related field.
5 years relevant experience required (or equivalent combination of education, training, and experience).
Intermediate knowledge of SAS and familiarity with CDISC/ADaM data standards.
Working knowledge of GCP, ICH guidelines, and clinical research regulatory requirements.
Ideal Candidate Profile
Experienced in leading statistical programming teams and managing end-to-end deliverables for clinical studies.
Proficient in complex statistical methods applicable to clinical trials and associated software tools.
Demonstrates strong organizational skills with accountability for timelines, budgets, and quality compliance.