Therapeutics Inc. · 14 hours ago
Sr. Statistical Programmer
United States
Full-time
Remote
Senior Level, Lead/Staff
$100K/yr - $140K/yr
8+ years expTherapeutics Inc. is a full-service dermatology CRO with over 25 years of experience, recognized as one of San Diego’s Top Workplaces. The Sr. Statistical Programmer will be responsible for generating analysis datasets and supporting statistical analysis for clinical trials, ensuring quality control and documentation throughout the programming process.
BiotechnologyHospitalityMedicalTherapeutics
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 Inc.
Therapeutics Inc.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$3M2011-01-28Series Unknown· $3M
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