Senior/Principal Statistical Analyst

TG Therapeutics, Inc.; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a talented Statistical Analyst for a contract role. The candidate will design, implement, validate, and document statistical programs to support clinical research and regulatory submissions, collaborating closely with biostatisticians, data managers, and clinical scientists.

Independent programming and CRO oversight are essential. This is a one-year term contract with potential extension based on business needs and performance.

Qualifications

• 4+ years of hands-on statistical programming experience in pharma/biotech.

Responsibilities

• Plan, develop, validate, and maintain SAS programs for statistical analyses of clinical trial data.
• Author and review programming specifications and maintain traceability between source data and outputs.
• Ensure accuracy, efficiency, and regulatory compliance (CDISC SDTM/ADaM).
• Perform QC checks on programs/outputs from CROs or other programmers.
• Review SAPs and study documentation.
• Other programming activities as required.

Skills

SAS programming

CDISC SDTM/ADaM

CRO oversight

Regulatory submissions

Statistical programming

SAP review

Education

Master’s degree or higher in Biostatistics

Job description

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 approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) in the US and European Commission.

Position

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.

This is a contractor position with an initial one-year term, subject to extension based on business needs and performance.

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.
• Other programming activities as required.

Qualifications

• At least 4 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.
• Experience in regulatory submissions.
• Good understanding of industry and regulatory standards such as CDISC (SDTM, ADaM) and 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.