#976 - Biostatistician-II

Job Opportunity only available for professionals located in Latin America . We're seeking an experienced Biostatistician-II to support our client's clinical development programs within the Biometrics organization. This role is intended for a biostatistician with 2–3 years of pharmaceutical industry experience who can independently support statistical activities for clinical trials and contribute meaningfully to regulatory submissions and inspection readiness. The Biostatistician-II will serve as a key statistical partner to cross-functional teams, ensuring high-quality, compliant, and submission-ready analyses that support clinical and regulatory decision-making. Requirements: Advanced English level (B2/C1/C2) to ensure fluent communication across teams. 2–3 years of statistical programming experience within a pharmaceutical, biotechnology, or clinical research organization. Strong hands-on experience with SAS for clinical trial programming; working knowledge of R preferred. 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. Responsibilities: Serve as the primary statistical support for assigned clinical studies or components of larger development programs Provide 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). Oversee and/or validate statistical analyses performed by statistical programmers, ensuring alignment with approved SAPs and regulatory expectations. Ensure all statistical deliverables are submission-ready, traceable, and inspection-ready , 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 integrity. 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 continuous improvement of biometrics standards, processes, templates, and best practices. May provide informal guidance or mentoring to junior biostatisticians. What do we offer? 100% Remote work. Competitive salary in USD. Type of contract: Independent Contractor with Venon Solutions LLC. Contract duration: Long-term. 2 weeks of PTO (paid time off). Paid Holidays: from the Client's calendar (USA) Working hours: Full-time EST timezone , fully committed.