About the job Sr. Principal, Biostatistics
Location: Remote
Type: Long Term Contract
Overview
Remote long term contract role supporting a global pharmaceutical client focused on advancing clinical development. Requires a senior-level biostatistician with proven leadership across trial design, statistical reporting, and regulatory submissions. Strong expertise in SAS, ICH guidelines, and CDISC standards essential.
Key Responsibilities
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Provide statistical leadership from protocol development through statistical reporting.
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Draft and review Statistical Analysis Plans (SAPs), shell tables, and derived variable specifications.
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Collaborate with Clinical Data Management and Programming teams to ensure data quality and integrity.
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Review CRFs, database design, edit checks, and oversee data surveillance activities.
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Conduct statistical validation and provide support for efficacy/safety analyses, data interpretation, and report drafting.
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Participate in regulatory filing efforts, responding to agency questions, and contributing to submission packages.
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Guide CRO partners and internal teams to ensure timelines and deliverables are met.
Required Skills & Experience
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Ph.D. in Statistics or Biostatistics with 4+ years of relevant experience OR
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MS in Statistics or Biostatistics with 6+ years in the pharmaceutical/CRO industry
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Strong SAS programming experience
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Familiarity with ICH guidelines, CDISC standards, and FDA regulatory expectations
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Demonstrated leadership in overseeing CRO deliverables and managing cross-functional collaboration
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Excellent communication, time management, and analytical thinking skills
Preferred Competencies
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Ability to multitask and adjust to shifting priorities in a fast-paced environment
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Proven problem-solver with a collaborative, team-oriented approach
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Experience mentoring or guiding junior statisticians and programmers
Work Authorization & Additional Info
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Remote position
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No relocation or visa sponsorship provided