Therapeutics Inc.
The only full-service dermatology CRO that takes products from concept to approval.
Senior Statistical Programmer
Location
California
Posted
43 days ago
Salary
$100K - $140K / year
Bachelor Degree8 yrs expEnglishSQL
Job Description
• 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.
Job Requirements
- Bachelor’s degree in Statistics, Mathematics, or in a related field; Master’s preferred.
- 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.
- 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.
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