TG Therapeutics, Inc. · 1 month ago
Principal Statistical Analyst
United States
Full-time
Remote
Senior Level, Lead/Staff
5+ years expTG Therapeutics is a fully-integrated, commercial-stage biopharmaceutical company focused on developing novel treatments for B-cell diseases. They are seeking a Principal Statistical Analyst to design, implement, validate, and document statistical programs that support clinical research and regulatory submissions, collaborating with various teams to ensure compliance and accuracy.
BiotechnologyHealth CareTherapeutics
Hiring Manager
Rachel Berger-Rosas, MBA
Responsibilities
Plan, develop, validate, and maintain SAS programs for statistical analyses of clinical trial data. Generate analysis datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions
Author and review programming specifications and maintain traceability between source data and outputs
Ensure accuracy, efficiency, and compliance with company standards and regulatory requirements (e.g., CDISC SDTM/ADaM)
Perform quality control checks and validation of programs and outputs produced by CRO or other statistical programmers
Review statistical analysis plans (SAP) and other study documentations
As leading statistical analyst in cross-functional teams including biostatistics, data management, clinical scientists and clinical operations
Review the design and development of case report forms and clinical study databases. Support data review and data cleaning
Participate in process improvement initiatives and contribute to programming standards and best practices
Other programming activities as required
Qualification
Required
At least 5 -years of hands-on statistical programming experience in the pharmaceutical or biotechnology industry
Extensive experience and proven skills in the use of SAS to develop and validate analysis datasets, tables, listings, and figures
Good understanding of industry and regulatory standards such as CDISC (SDTM, ADaM) is required
Familiarity with regulatory requirements (FDA, EMA, ICH guidelines)
Extensive experience in working with CROs and overseeing CRO deliverables
Strong understanding of clinical trial data structures and statistical concepts
Excellent problem-solving, communication, and collaboration skills
Ability to manage multiple projects and meet tight deadlines in a fast-paced environment
Master's degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related field
Preferred
Knowledge of R is a plus
Company
TG Therapeutics, Inc.
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.
201-500 employees
H1B Sponsorship
TG Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Hercules Capital
2024-08-06Post Ipo Debt· $250M
2022-01-04Post Ipo Debt· $70M
2019-12-24Post Ipo Equity· $50M
Leadership Team
M
Mark Glick
VP Program Management
Recent News
2026-01-07
TG Therapeutics, Inc.
2025-11-28
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