I’m currently supporting a clinical-stage organisation with the search for an experienced Principal Statistical Programmer with strong Oncology experience. Apply (by clicking the relevant button) after checking through all the related job information below. 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 OSHands-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. xhqgsiq 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.
