Senior Biostatistician Consultant - LATAM

Description

Summary: Join a leading biometrics consulting firm as a Senior Biostatistician Consultant, contributing to clinical trials for top pharma and biotech clients. Highlights: 1. Work with top-tier US pharma/biotech clients 2. Develop and review Statistical Analysis Plans (SAPs) 3. Utilize strong SAS programming and CDISC expertise **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