The Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
- 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.
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 4 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 of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a plus.
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.