Open Position
Title: Principal Statistical Analyst
Location: Remote
If you are interested in the below position, please send your resume to [email protected] 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 approval from the United States Food and Drug Administration (FDA) 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, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in New York City, New Jersey, and Raleigh, NC. For more information, visit www.tgtherapeutics.com.
Role
The Principal Statistical Analyst will help lead the statistical analysis at TG Therapeutics, by working closely with the statistical and clinical teams. Additionally, this position will perform independent statistical programming and oversee Clinical Research Organization’s (CRO) activities. The position reports to the VP of Biostatistics.
Key Responsibilities
– Being statistical programming lead in clinical development programs and study teams
– Develop and execute statistical analysis deliverables (TFL) in a timely and high-quality manner
– Author and review SDTM and ADaM datasets specifications for datasets programming
– Assess and perform quality control checks/validation of SAS code and output produced by CRO or other statistical programmers for SDTM datasets, ADaM datasets, and TFLs
– Review statistical analysis plans (SAP) and other study documentations
– Provide input in the design and development of case report forms and clinical study databases
– Other programming activities as required
Professional Experience/Qualifications
––At least 5 years of hands-on experience in statistical programming in the pharmaceutical industry or CRO
––Extensive experience and proven skills in the use of SAS to develop and validate analysis datasets, tables, listings, and figures. Knowledge of R or other statistical software is a plus.
––Good understanding of industry and regulatory standards such as CDISC (SDTM, ADaM)
––Extensive experience in working with CROs, overseeing CRO deliverables
––Excellent verbal and written communication and interpersonal skill
Education
––Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
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.