Job Openings Sr. Principal, Biostatistics

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

  • 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