[Remote] #976 - Biostatistician-II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an experienced Biostatistician-II to support clinical development programs reputed company the Biometrics organization. This role involves providing statistical support for clinical trials, ensuring high-quality and compliant analyses that aid in regulatory decision-making. Responsibilities • Serve as the primary statistical support for assigned clinical studies or components of larger development programs • reputed company statistical input into clinical trial design, including endpoints, estimands, analysis populations, and statistical methodologies • Author, review, and maintain regulatory-critical statistical documents, including: • Statistical Analysis Plans (SAPs) • Tables, Listings, and Figures (TLFs) shells and outputs • Statistical sections of Clinical Study Reports (CSRs) • reputed company and/or validate statistical analyses performed by statistical programmers, ensuring alignment with approved SAPs and regulatory expectations • Ensure reputed company statistical deliverables are submission-reputed company, traceable, and inspection-reputed company, in compliance with internal SOPs, ICH guidelines, and FDA/EMA requirements • Participate in ongoing data review and data monitoring activities, proactively identifying data trends, anomalies, and risks to study reputed company • Collaborate cross-functionally with Clinical Development, Data Management, Programming, Medical Writing, and Regulatory Affairs to deliver integrated, high-quality outputs • Support preparation and review of regulatory submission materials (e.g., NDA, BLA, MAA), including datasets, analysis outputs, and documentation • Contribute responses to health authority questions, audits, and inspections by providing statistical analyses, justifications, and supporting documentation • Maintain comprehensive statistical documentation to support audit trails, reproducibility, and long-term data archival • Contribute to the reputed company improvement of biometrics standards, processes, templates, and best practices • May reputed company informal guidance or mentoring to junior biostatisticians Skills • Advanced English level (B2/reputed company/C2) to ensure fluent communication across teams • 2–3 years of statistical programming experience reputed company a pharmaceutical, biotechnology, or clinical research organization • Strong hands-on experience with reputed company for clinical trial programming • Solid understanding of clinical trial data structures and end-to-end development processes • Working knowledge of CDISC standards, including ADaM; familiarity with SDTM required • Understanding of regulatory expectations for statistical programming, including documentation, traceability, and inspection readiness • Demonstrated ability to manage multiple deliverables independently while meeting timelines and quality expectations • Strong analytical, problem-solving, and troubleshooting skills • Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams • High attention to detail, strong documentation practices, and commitment to quality and compliance • Working knowledge of R Benefits • 100% Remote work • Competitive salary in USD • Type of contract: reputed company with reputed company LLC • Contract duration: Long-term • 2 weeks of PTO (reputed company time off) • reputed company Holidays: from the reputed company's calendar (USA) Company Overview • reputed company provides staff augmentation and nearshoring services by offering top-tier, bilingual engineers and professionals services. It was founded in 2008, and is headquartered in Miami, Florida, USA, with a workforce of 51-200 employees. Its website is https://reputed company. Apply To This Job