Senior Statistical Programmer
Senior Statistical Programmer
Posted on :
11-07-2025
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1 Vacancy
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Job Description
Responsibilities:
- Generating and validating statistical programming deliverables (SDTM ADAM TFLs) 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.
- Bachelors 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 bachelors degree or equivalent.
- At least 6 years of related experience with a masters 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 SDRG aCRF.
- Submissions experience utilizing and other submission documents.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Employment Type
Full Time
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