Principal Statistical Analyst

Location: Remote

If you are interested in the below position, please send your resume to careers@tgtxinc.com and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.

Role

We are seeking a talented and motivated Statistical Analyst to join our growing team at a leading biotechnology company. The candidate will play a key role in the design, implementation, validation, and documentation of statistical programs to support clinical research and regulatory submissions. The candidate will collaborate closely with biostatisticians, data managers, and clinical scientists, independently perform statistical programming and oversee CRO activities.

Key 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.

Professional Experience/Qualifications

• 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. Knowledge of R is a plus.
• 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.

Education

• Master’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related field

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.