Senior Biostatistician Consultant - LATAM

Senior Biostatistician Consultant - LATAM (Full Time)

US-based biometrics consulting firm with over 30 years in the industry. Founded in 1993, they provide biostatistics, statistical programming, and data management resources to leading pharma and biotech companies — clients include names like Regeneron, Cytokinetics, Exelixis, Apellis, and BridgeBio. 95% of their staff hold advanced degrees with an average of 15 years of experience. This is a new offshore initiative — you would be one of the first Senior Biostatistician hires from Latin America, working directly with a top-tier US pharma/biotech client.

What You'll Do

• Develop and review Statistical Analysis Plans (SAPs), including analysis dataset and TLG specifications
• Perform statistical analyses and prepare clinical study reports, including integrated summaries for regulatory submissions
• Participate in study design discussions, sample size calculations, and protocol development
• Review CRFs, data review guidelines, edit check specifications, and data validation plans
• Use SAS programming daily for QC of critical outputs, efficacy/safety tables, and collaboration with statistical programmers
• Ensure compliance with CDISC requirements (SDTM, ADaM) for regulatory submissions
• Collaborate with internal and external functions (CROs, software vendors, clinical development partners)
• Review and/or author data transfer specifications and SOPs related to statistical programming practices
• Present and explain statistical methodology clearly to non-statistician stakeholders

Required Qualifications

• Master's degree minimum in Statistics, Mathematics, or Applied Mathematics — PhD strongly preferred
• 5+ years supporting clinical trials in pharma, biotech, or CRO — commercial experience required
• At least 3 years in a commercial clinical trials environment (pharma/biotech/CRO) — hospital or academia-only backgrounds will not be considered
• Strong SAS programming skills — used daily for QC, efficacy/safety tables, and programmer collaboration
• Solid CDISC expertise (SDTM, ADaM) for regulatory submissions
• Experience with SAP development, TFL programming, and integrated summaries for FDA submissions
• Strong English communication skills — written and verbal

Nice to Have

• CRO experience (strongly desired)
• Oncology therapeutic area experience
• R programming knowledge
• PK/PD modeling or biomarker integration experience
• PhD in Statistics or related field