Therapeutics Clinical Research · 12 hours ago
Sr. Statistical Programmer
United States
Full-time
Remote
Senior Level, Lead/Staff
$100K/yr - $140K/yr
8+ years expTherapeutics Clinical Research is a full-service dermatology CRO that prides itself on collaboration and diversity. The Sr. Statistical Programmer will generate analysis datasets and provide statistical programming support for clinical trials, ensuring quality control and compliance with industry standards.
MedicalPharmaceuticalProduct ResearchProfessional ServicesUsability Testing
Responsibilities
Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications
Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files
Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
Maintain complete and auditable documentation of all programming activities
Review output across SAS programs to ensure consistency
Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
Assist Clinical Data Managers with data review via SAS programmed data checks and listings
Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
Participate in the development and/or maintenance of departmental procedures and standards
Review CRFs, edit check specifications, and table mock-ups
Work collaboratively with cross functional groups, study team, and vendors
May assist in creation of table, figure, or listing mockups under supervision of statisticians
Qualification
Required
Bachelor's degree in Statistics, Mathematics, or in a related field
Minimum of 8 to 10 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL
Demonstrate extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
Excellent communication and interpersonal skills to effectively interface with others
Preferred
Master's degree
NDA submission experience
Company
Therapeutics Clinical Research
Therapeutics Clinical Research is a clinical research facility engaged in testing investigational medications prior to FDA approval.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase