As a Senior Programmer, you will perform programming activities for the creation and validation of SDTM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology.
How you will contribute:
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming.
- Applying your CDISC know-how and proficiency to create and validate safety and efficacy SDTMs,
- Creating and validating pooled analysis datasets (ADaMs), tables, listings, and figures (TLFs);
- Preparing submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21
- Generating complex ad-hoc reports
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
At least 5 years of relevant statistical programming experience in a clinical development environment.
BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences, or other related scientific subjects.
- 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.
- Ability to implement the latest CDISC SDTM standards (production/validation).
Familiarity with pooled ADaM data such as in an ISS or other pooled studies dataset.
Experience with Oncology is required.
- Submissions experience utilizing define.xml and other submission documents such as SDRG or ADRG are required.
Very good oral and written English communication skills.
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