Lead, Oncology Statistical Programming

Orion Corporation; Cambridge (MA); Hybrid; USD 130,000 - 230,000; Full time

Job summary

Orion Corporation is seeking a Statistical Programming Lead to guide oncology programming for Phase I–III programs. You will provide hands‑on leadership, ensure CDISC standards, and deliver submission‑ready outputs in collaboration with Biostatistics, Data Management and Regulatory Affairs.

The role reports to the Head of Clinical Development Data Services and may be based in Cambridge (MA) or Cambridge (UK). A focus on automation and AI‑assisted programming is encouraged.

Qualifications

• This role requires a hands‑on programming lead for clinical studies and regulatory submissions.
• Deep knowledge of CDISC standards (SDTM/ADaM) and submission requirements.
• Experience with automation, standardization and process improvements in programming.

Responsibilities

• Lead statistical programming for oncology studies from startup to regulatory submission.
• Translate study objectives and submission requirements into executable deliverables.
• Develop and validate SDTM, ADaM, TLFs, and define.xml files.
• Ensure high‑quality, on‑time, regulation‑compliant outputs.
• Mentor programmers and drive tooling, macros, and best practices.

Skills

SAS programming

Base SAS

Macro programming

SQL

R or Python familiarity

CDISC SDTM/ADaM know‑how

Regulatory submissions

Automation & process improvement

Technical leadership

Education

Bachelor's or Master’s in Statistics/Biostatistics/CS/Math

Advanced degree preferred

Tools

R

Python

define.xml tooling

Job description

Orion Corporation is seeking a Statistical Programming Lead to guide oncology programming for Phase I–III programs. You will provide hands‑on leadership, ensure CDISC standards, and deliver submission‑ready outputs in collaboration with Biostatistics, Data Management and Regulatory Affairs.

The role reports to the Head of Clinical Development Data Services and may be based in Cambridge (MA) or Cambridge (UK). A focus on automation and AI‑assisted programming is encouraged.