Senior Biostatistician Consultant - LATAM (Full time)
About the client
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
