Your work will include generating Tables, Listings, and Figures (TLFs) for analysis purposes. You will ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Supporting the Programming Lead, you may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, you will mentor Statistical Programmers and external consulting resources, demonstrating a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively. Independence is crucial in this role.
Accountabilities
- Support development of technical programming specifications for SDTM, ADS or ADaM standards.
- Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications.
- Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
- Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications.
- Manage external vendors and contract programmers.
- Provide project progress updates of programming activities.
- Review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer, junior-level Programmers and contract staff.
- Support project leadership ensuring that department standards are implemented in all studies.
- Contribute ideas and thoughts towards the optimization of standard operating procedures.
- Lead team meetings when appropriate.
- Any other activities as required.
Essential Skills/Experience
- Minimum of 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Proven ability to:
- Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
- Independently and collaboratively resolve problems
- Clearly communicate processes and standards with management and team members
- High competence in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL
- Knowledge and implementation of:
- SDTM and ADaM principles
- Relational Databases
- Good Clinical Practice principles
- Good Programming Practice principles
- 21CFR Part 11 Standards principles
- Integrated Summary Safety/Efficacy Analyses
- Safety data and Coding Dictionaries (MedDRA and WHODD)
- ICH eCTD format
- Integrated Summary Safety/Efficacy Analyses
Desirable Skills/Experience
- Safety data and Coding Dictionaries (MedDRA and WHODD)
- ICH eCTD format
