Perform advanced SAS programming to create and validate safety and efficacy SDTMs and pooled ADaM datasets for ISS and submission packages (define.xml, reviewer's guide). Produce TLFs and ad-hoc reports, apply CDISC standards, support oncology-focused studies, and prepare submission-ready deliverables using Pinnacle 21 and related tools.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Statistical Programmer II you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
Position Overview:
As a Senior Statistical Programmer, you will perform programming activities for the creation and validation of SDTM (including efficacy SDTMs) as well as ADaM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology. ISS and ADaM knowledge are a must have.
How you will contribute:
- Performing data 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
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).
Working knowledge with pooled ADaM data such as in an ISS or other pooled studies dataset.
Recent experience with Oncology is required.
- Submissions experience of creating define.xml and other submission documents such as sSDRG or ADRG are required.
Very good oral and written English communication skills.
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