Senior Statistical Programmer
Katalyst Healthcares & Life SciencesBoston, MA, United States30+ days ago
Job type
- Full-time
Job descriptionBachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above. As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late stage clinical trials. Having experience / expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters). Up-versioning activities to specific versions of SDTM. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF. Submissions experience utilizing define.xml and other submission documents. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Responsibilities :
- Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK / PD Modeling and Simulation spanning all therapeutic areas.
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS / Client), utilizing SAS programming.
- Generating complex ad-hoc reports utilizing raw data.
- Applying strong understanding / experience of Efficacy analysis.
- Creating and reviewing submission documents and eCRTs.
- Communicating with and / or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries.
- Performing lead duties when called upon.
- 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
- Develop and validate global programming standards for ADaM datasets.
- Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
- Design and develop complex programming algorithms.
- Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
- Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
Requirements :
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Senior Programmer • Boston, MA, United States
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