Director, Biostatistics - Early-Phase Oncology (Hands-On)

BioTalent; Watertown (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

BioTalent seeks a Director of Biostatistics to lead the statistical strategy for its early-phase oncology portfolio in Watertown, MA. You will oversee design, modeling, programming, and interpretation of emerging data, ensuring robust analysis from FIH dose escalation through PoC.

You will directly contribute to trial design, simulations, and regulatory submissions, using R and SAS, with SDTM/ADaM compliance and clear communication to senior stakeholders.

Qualifications

• PhD in Biostatistics or related field with strong biotech/pharma experience.
• MS with substantial industry experience acceptable.
• Min. 3 years hands-on in early-phase oncology trials (Phase I/II).
• Experience supporting oncology studies from protocol design to CSR.
• Strong programming in R and SAS; familiarity with SDTM, ADaM.

Responsibilities

• Lead statistical design and execution for Phase I/II oncology studies.
• Develop sample size calculations, randomization strategies, adaptive designs, and trial simulations.
• Provide statistical leadership from protocol development through CSR.
• Prepare SAPs and TLFs; communicate results to leadership.

Skills

Clinical trial design

Statistical leadership

Regulatory submissions

Clear communication

Education

PhD in Biostatistics

MS in Biostatistics

Tools

R

SAS

CDISC SDTM/ADaM

R/Shiny

Job description

BioTalent seeks a Director of Biostatistics to lead the statistical strategy for its early-phase oncology portfolio in Watertown, MA. You will oversee design, modeling, programming, and interpretation of emerging data, ensuring robust analysis from FIH dose escalation through PoC.

You will directly contribute to trial design, simulations, and regulatory submissions, using R and SAS, with SDTM/ADaM compliance and clear communication to senior stakeholders.