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.
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