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

• Provide statistical leadership from protocol development through statistical reporting.

• Draft and review Statistical Analysis Plans (SAPs), shell tables, and derived variable specifications.

• Collaborate with Clinical Data Management and Programming teams to ensure data quality and integrity.

• Review CRFs, database design, edit checks, and oversee data surveillance activities.

• Conduct statistical validation and provide support for efficacy/safety analyses, data interpretation, and report drafting.

• Participate in regulatory filing efforts, responding to agency questions, and contributing to submission packages.

• Guide CRO partners and internal teams to ensure timelines and deliverables are met.

Required Skills & Experience

• Ph.D. in Statistics or Biostatistics with 4+ years of relevant experience OR

• MS in Statistics or Biostatistics with 6+ years in the pharmaceutical/CRO industry

• Strong SAS programming experience

• Familiarity with ICH guidelines, CDISC standards, and FDA regulatory expectations

• Demonstrated leadership in overseeing CRO deliverables and managing cross-functional collaboration

• Excellent communication, time management, and analytical thinking skills

Preferred Competencies

• Ability to multitask and adjust to shifting priorities in a fast-paced environment

• Proven problem-solver with a collaborative, team-oriented approach

• Experience mentoring or guiding junior statisticians and programmers

Work Authorization & Additional Info

• Remote position

• No relocation or visa sponsorship provided