Sr. Principal Statistics

Overview

Remote

$60

Contract - W2

Contract - 6 Month(s)

Skills

Biostatistics

Clinical Trials

CDISC

Pharmaceutics

SAS

Statistics

Licensing

Leadership

Job Details

Job Title: Sr. Principal Statistics

Location: Remote Duration: 6 Months
Employment Type: W2 Contract
Experience Level: Mid-Senior
Education Required: Ph.D. or MS in Statistics or Biostatistics
Industry: Pharmaceuticals

Job Summary:

The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support.

Key Responsibilities:

Review protocols and contribute statistical design elements including sample size, analysis methods, and study duration.
Review CRFs, database designs, and edit check specifications.
Prepare or review SAPs, TFL shells, and variable derivation specs.
Work closely with statistical programmers and data managers to ensure data quality for efficacy and safety variables.
Provide statistical and validation support for analysis datasets and TFLs.
Review study reports, manuscripts, and statistical documentation.
Assist with regulatory responses and additional statistical analyses.
Monitor study progress and ensure timelines are met.
Oversee CRO statisticians and programmers; review CRO deliverables.
Coordinate cross-functionally across clinical, data, and regulatory teams.

Required Qualifications:

Ph.D. (with 4+ years) or MS (with 6+ years) in Statistics/Biostatistics.
Strong experience in pharmaceutical or CRO environments.
Proficiency in SAS programming.
Strong understanding of industry standards: ICH, CDISC, FDA guidelines.
Experience reviewing CRFs, SAPs, and statistical TFLs.
Strong communication, leadership, and time-management skills.
Ability to work independently and lead CRO teams.

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