Job Description
What You’ll Do:
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We are seeking an experienced statistical programmer to join our Functional Service Provider (FSP) team. This role is responsible for providing high-level technical expertise in the transformation and analysis of clinical trial data. The ideal candidate will bring a deep understanding of CDISC standards and a meticulous approach to SAS programming.
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Key Responsibilities:
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- End-to-End Programming: Conduct independent validation and quality checks of statistical programming deliverables, including SDTM, ADaM, and TFLs from Biometrics Service Providers; independently develop customized analysis datasets.
- Reporting Deliverables: Program and validate complex TFLs for ad-hoc and post-hoc analyses to support emerging clinical questions, publications, internal decision-making, and regulatory submissions.
- Regulatory Compliance: Ensure all deliverables meet CDISC standards (SDTMIG, ADaMIG) and comply with regulatory (e.g., FDA/EMA) guidelines.
- Communication: Collaborate closely with study lead programmers and statisticians to deliver results in a timely and accurate manner.
- Submission Documentation: Review technical documentation including Define.xml, Reviewer’s Guides (cSDRG/ADRG), and analysis metadata.
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Qualifications:
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- Education: Master’s degree in Biostatistics, Statistics, or a related field
- Experience: Minimum of 3 years of hands-on statistical programming experience within the Pharmaceutical or CRO industry; Independent validation experience of datasets and statistical deliverables.
- SAS Master: Proficiency in SAS (Base, Stat, Macro, Graph) with a proven track record in a clinical environment.
- Standardization: Comprehensive knowledge of CDISC implementation and the ability to interpret protocol and complex statistical Analysis Plans (SAPs).
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Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA).
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