We are partnered with a global pharmaceutical company which is going through an exciting transformation and experiencing rapid growth due to pipeline realisation and optimisation.
As a result of this growth, a role has arisen in the biometrics division for an experienced Statistical Programmer to join the team!
Responsibilities:
- Designing, developing, maintaining, and validating (SAS) computer programs to derive, store, analyze and report clinical trial data. Ensure deliverables meet:
- expectations in timelines and quality;
- regulatory and key user groups (e.g. CDISC) requirements;
- operational efficiency;
- alignment with study clinical and statistical objective.
Primary tasks include:
- Produce TLFs under direction of biostatistician
- Design and maintain statistical datasets that support multiple stakeholder groups
- Map and/or pool raw datasets into derived and analysis datasets
- Provide input into SAP, analysis specifications and data presentations for clinical trials
- Programming validation utilizing global standards, following departmental SOPs and good programming practices
Additional activities and expectations:
- Ensure that all activities under responsibility are properly documented (traceability of changes, data specifications, analysis validation) according to internal procedures.
- Active involvement in training preparation and presentation for continuous team improvements.
- Collaborate effectively with Statistics & Data Management internal and external partners in all activities where programming is needed.
- Strive for efficiency, continuous improvement, and creation of added value, in particular by ensuring standardization of programming activities in order to reduce development costs and timelines while maintaining required quality.
- Perform other tasks as per line management discretion.
Requirements:
- Consistent experience as a statistical programmer on several concurrent projects.
- 3+ years of experience in a life science industry in clinical development (either pharmaceutical, medical device or CRO).
- Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
- Working knowledge of Statistics, clinical trials, relevant regulatory guidelines, and basic project management.
- Track record of successful submission activities and project or team lead experience.
- Expert in application of "state-of-the-art" programming methodology in the projects under responsibility
Interested? drop me a message:
