Senior Statistical Programmer
Consult
I’m currently supporting a clinical-stage organisation with the search for an experienced Principal Statistical Programmer with strong Oncology experience.
This is a senior, hands-on contract opportunity for a programmer who has led programming activities across late-stage Oncology studies and regulatory submissions.
Key Requirements
- 10+ years of statistical programming experience , including 5+ years within Oncology
- Strong experience with Oncology endpoints including RECIST, ORR, PFS and OS
- Hands-on experience with Kaplan-Meier curves, Cox proportional hazards models, log-rank tests and forest plots
- Experience working with biomarker and/or genomic data
- Experience in immuno-oncology, CAR-T and/or combination therapies
- Previous experience acting as Statistical Programming Lead (SPL) for end-to-end Oncology studies or programmes
- Strong regulatory submission experience, including NDA, BLA, eCTD, ISS/ISE and submission-ready deliverables
- Experience producing and reviewing CDISC-compliant datasets and documentation , including SDTM, ADaM, Define.xml, annotated CRFs and reviewer guides (aSDRG/cSDRG)
- Experience developing time-to-event datasets and outputs for Oncology endpoints
- Strong understanding of FDA and EMA requirements for statistical programming and regulatory submissions
- Experience with standardisation and automation across studies and/or multiple Oncology indications
If you have the required Oncology experience and are available for contract work, please get in touch with an up-to-date CV/resume and details of your availability.
Vacancy posted 3 days ago
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