Senior Statistical Programmer

Provide programming feedback to Statisticians and align on shells.\nBuild SDTM from raw sources with end-to-end traceability to CRF and EDC exports.\nPerform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains.\nApply controlled terminology and clinical dictionaries (Meddra, WHODrug, etc) in SDTM mapping\nPrepare SDRG and SDTM Define.xml. Run and resolve SDTM Pinnacle 21 findings.\nCreate ADaM specifications from SAP and shells with clear derivation rules and SDTM-to-ADaM traceability.\nProgram ADaM across ADSL, BDS, OCCDS, and time-to-event. Produce ADaM Define.xml and ADRG.

Close ADaM Pinnacle 21 findings.\nUnderstand and build TFL mock shells consistent with SAP and ADaM structure. Program and validate TFLs in SAS and R.\nExecute QC: independent review, double programming where applicable, internal checklists, full documentation discipline, and issue tracking to closure.\nAssemble submission-ready packages: datasets, programs, XPT, Define, ADRG, SDRG, meeting expectations of EMA, FDA, PMDA and other regulatory authorities.\nLead or support pooled analyses and exploratory requests. Coordinate ISS and ISE datasets and outputs when required.\n\nRequired Skills\nStatistical knowledge appropriate for programmers.\nStrong SAS Base and Macro with ability to modify and maintain shared code and macros.\nWorking R for data manipulation, automation, and reproducible reporting.\nProven validation mindset and familiarity with GCP, ICH, and CDISC compliance expectations.\nClear, concise English.

Effective collaboration with Statisticians, Data Managers, Medical Writers, and Sponsor teams across time zones.\nAccountable, detail-focused, and organized. Able to plan timelines, communicate risks early, and deliver to quality and schedule in a multi-study environment.\n\nPreferred Skills\nExperience as Statistical Programmer within a CRO or pharmaceutical company is required.\n\nPay range and compensation package\n\nWhy Join VALOS?\n\nBe part of a specialized and collaborative international team with offices in Italy, USA and East Europe\nWork on a diverse portfolio of clinical studies across therapeutic areas\nBenefit from flexible working arrangements and continuous professional development\nContribute to high-impact research improving patient outcomes worldwide