Senior Biostatistician – Clinpharm
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Job Description
Senior Biostatistician supporting SAPs, PK/PD analyses, and clinical trial statistics at Syneos Health. Applying SAS and CDISC standards across Phase I clinical pharmacology studies.
Responsibilities:
- Review Statistical Analysis Plans (SAPs) in alignment with protocols and regulatory requirements
- Develop mock shells and define analysis datasets
- Support randomization activities
- Perform protocol reviews and contribute statistical inputs during study design and execution
- Review Clinical Study Reports (CSRs) and ensure accuracy and consistency of statistical outputs
- Support Phase I studies, including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A)
- Validate Tables, Listings, and Figures (TFLs) and ensure compliance with quality standards
- Work with CDISC standards (SDTM/ADaM)
- Collaborate with statistical programming teams
- Apply SAS for statistical analyses and data review activities
- Take initiative and challenge the status quo in a competitive and changing environment
Requirements:
- 5–8 years of experience as a Senior Biostatistician
- Experience reviewing Statistical Analysis Plans (SAPs) in alignment with protocols and regulatory requirements
- Experience developing mock shells and defining analysis datasets
- Experience with randomization activities
- Experience performing protocol reviews and contributing statistical inputs during study design and execution
- Experience reviewing Clinical Study Reports (CSRs)
- Experience supporting Phase I studies, including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A)
- Experience validating Tables, Listings, and Figures (TFLs)
- Knowledge of CDISC standards (SDTM/ADaM)
- Experience with SAS for statistical analyses and data review activities
- Equivalent experience, skills, and/or education may be considered
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities
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