Principal Statistical Analyst

TG Therapeutics, Inc.; United States; On-site; USD 80,000 - 120,000; Full time

Job summary

A leading biotechnology company in the United States is seeking a Statistical Analyst to join their team. The role involves developing and validating statistical programs using SAS for clinical trials, ensuring regulatory compliance, and collaborating with cross-functional teams. Ideal candidates should have at least 5 years of experience in statistical programming within the pharmaceutical field and possess a Master's degree in a related area.

Qualifications

• 5+ years of statistical programming experience in the pharmaceutical or biotechnology industry.
• Good understanding of CDISC standards (SDTM, ADaM).
• Experience working with CROs and overseeing deliverables.

Responsibilities

• Develop and maintain SAS programs for clinical trial data analysis.
• Perform quality control checks and program validations.
• Act as a leading analyst in cross-functional teams.

Skills

SAS programming

Statistical analysis

Collaboration skills

Problem-solving

Education

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

Tools

SAS

R

Job description

Human Resources Business Partner @ TG Therapeutics | Talent Acquisition & Development

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 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.

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.
• Act 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.

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.