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 biostatistics experience within a pharmaceutical, biotechnology, or clinical research organization.
- Solid understanding of clinical trial design, statistical methodology, and end-to-end drug development processes.
- Strong hands-on experience with SAS for clinical trial analyses; working knowledge of R preferred.
- Proficient understanding of CDISC standards (SDTM and ADaM) and their application in regulatory submissions.
- Working knowledge of applicable regulatory guidance (e.g., ICH E9, E3, and relevant FDA/EMA guidance)
- Demonstrated ability to work independently while managing multiple studies or deliverables.
- Strong written and verbal communication skills, with the ability to clearly explain statistical concepts to non-statistical stakeholders.
- 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 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.
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