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
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
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
