Senior Biostatistician – Clinpharm

🔥 34 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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