Senior Statistical Programmer

Key Responsibilities
- Oversee and/or contribute to in-house statistical programming deliverables, including CDISC conversion.
- Provide planned, ad hoc, and exploratory statistical programming services, including quality control.
- Review and approval of technical specification documents (e.g., CDISC specs; TFL mock shells).
- Review and approval of externally delivered programming outputs (e.g., SDTM/ADaM datasets; TFL outputs) with a focus on quality.
- Serve as designated lead Statistical Programmer on clinical trial(s).
- Perform ad-hoc programming to support internal decision-making.
- Deliver SDTM and ADaM datasets, and Tables/Figures/Listings.
- Produce and perform quality control of datasets/output for: CSRs, DSURs, PBRERs, Investigator Brochures, etc.
- Produce datasets/output to support PK/PD analyses.
- Support submission planning (e.g., data pooling strategy; programming input to High Level Documents; responses to regulatory questions).
- Develop quality standards to improve efficiency and metadata reuse.
- Develop a comprehensive validation process for in-house programming deliverables.

Qualifications & Skills (Experience & knowledge)
- 5+ years of relevant experience with a mathematical, statistical, computer science, or life science degree.
- Industry knowledge; drug development lifecycle; CDISC standards; extensive Health Authority requirements knowledge.
- SAS programming skills (Base, Macro); SQL; SAS Graph.
- Experience as lead programmer.
- Excellent written and verbal communication skills; ability to solve problems independently.
- R experience desirable (not required).

Essential Competencies
- Professional discretion and confidentiality; high prioritization; autonomy; proactive challenge anticipation.
- Result/deadline orientation; time management; collaboration; presentation; flexibility.