Senior Statistical Programmer-Spain
hace 2 semanas
Senior Statistical Programmer Lead single and multi‑study statistical programming for clinical trials, developing and maintaining annotated Case Report Forms (aCRFs), SDTM/ADaM datasets, tables, listings and figures (TLFs), and submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), and Clinical Study Reports (CSRs). Provide input on Statistical Analysis Plans (SAPs), TLF shells, DM documents, support data cleaning, use global SAS macros, and validate CDISC artefacts with Pinnacle 21. Responsibilities Act as Lead Statistical Programmer for multiple studies. Review scope of work, budgets, and identify out‑of‑scope tasks. Provide input to DM documents (eCRF, edit checks), SAPs, and TLF shells. Support data cleaning: program, report, review, and resolve statistical data issues in collaboration with other programmers and the Lead Biostatistician. Develop, maintain, and validate aCRFs, SDTM/ADaM specifications, and primary / QC statistical programs, ensuring compliance with CDISC IG, CT, and sponsor standards. Generate define.XML, Clinical SDTM Reviewer’s Guide (cSDRG), ADaM Reviewer’s Guide (ADRG), resolve findings collaboratively. Validate SDTM/ADaM datasets and define.XMLs using Pinnacle 21. Use global SAS macros to improve efficiency of SDTM/ADaM/TLF programming. Serve as Unblinded primary or QC Statistical Programmer for randomization plans, IDMCs, and IAs. Contribute to internal initiatives to enhance efficiency/quality of statistical programming deliverables. Stay current with industry and CDISC standards, ICH/Regulatory guidance, and sponsor requirements. Mentor junior Statistical Programmers (optional). Requirements Education: Bachelor’s degree in Statistics, Computing Sciences or related field; Master’s degree preferred. Experience: Minimum 7 years in biotech, pharma, or CRO; at least 5 years in statistical programming and 2 years as Lead Statistical Programmer. Knowledge & Skills: Extensive exposure to clinical trial data, SAPs, TLF shells, and specifications; excellent SAS proficiency (certification an asset); XML programming knowledge; CDISC standards (certification an asset); deep understanding of ICH guidelines (E6, E9, E9‑R1), HC/FDA regulations, electronic submission requirements, and Pharmaceutical Industry Good Practice Practices; strong project planning, time‑management, organizational and communication skills; ability to work independently and collaboratively. Company Indero is a contract research organization specialized in dermatology, operating since 2000 with a reputation for high‑quality research and services. Based in Montreal, Indero is expanding in North America and Europe. Benefits Flexible work schedule Permanent full‑time position Company benefits package Ongoing learning and development opportunities Indero is committed to providing equitable treatment and equal opportunity to all individuals. Indero will provide accommodations during the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Spain. #J-18808-Ljbffr
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Senior Statistical Programmer-Spain
hace 2 semanas
Madrid, España Indero A tiempo completoThe Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as...
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Senior Statistical Programmer-Spain
hace 2 semanas
Madrid, España Indero (formerly Innovaderm) A tiempo completoSenior Statistical ProgrammerLead single and multi‑study statistical programming for clinical trials, developing and maintaining annotated Case Report Forms (aCRFs), SDTM/ADaM datasets, tables, listings and figures (TLFs), and submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), and Clinical Study Reports (CSRs). Provide...
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Senior Statistical Programmer
hace 1 semana
Madrid, España Warman O'Brien A tiempo completo**Senior Statistical Programmer** - Senior Programmer-Top 5 CRO-Remote Our client is a global CRO and is looking for an experienced Senior Statistical Programmer to join the company. **What is it like to work here?** Our client is an in innovative and exciting world-leading global CRO at the forefront of combining human science expertise with advances in...
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madrid, España Kelly Science, Engineering, Technology & Telecom A tiempo completoA leading clinical research firm is seeking a Senior Statistical Programmer in Madrid, Spain. This role involves developing SAS programs for clinical trials, ensuring data quality, and mentoring junior programmers. Candidates should have robust experience in statistical programming with a Master's or Bachelor's in a related field. Join us to contribute to...
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Senior Statistical Programmer I
hace 5 días
Madrid, España ICON plc A tiempo completoSenior Statistical Programmer - IndiaICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Statistical Programmer I to...
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Senior Statistical Programmer
hace 2 semanas
Madrid, Madrid, España ICON plc A tiempo completoSenior Statistical Programmer II - EMEAICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Statistical Programmer II to...
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Senior Statistical Programmer
hace 2 semanas
Madrid, España Indero (formerly Innovaderm) A tiempo completoA contract research organization is seeking a Senior Statistical Programmer to lead statistical programming for clinical trials. Responsibilities include maintaining datasets, supporting data cleaning, and validating submissions. This role requires a Bachelor's degree in a related field with a minimum of 7 years experience in biotech, pharma, or CRO,...
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Statistical Programmer II
hace 5 días
Madrid, España ICON plc A tiempo completoStatistical Programmer IIICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Statistical Programmer II/Data Scientist to join...
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Statistical Programmer II
hace 5 días
Madrid, España ICON plc A tiempo completoStatistical Programmer II (Data Scientist)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Statistical Programmer II/Data...
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Statistical Programmer II
hace 1 semana
Madrid, Madrid, España ICON plc A tiempo completoStatistical Programmer II (Data Scientist)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Statistical Programmer II/Data...
