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Job DetailsJob Title: Senior Statistical Programmer (CDISC focus)Location: With expertise spanning supply chain innovation, clinical trial support, and strategic consulting, we are committed to improving patient outcomes and are looking for a talented Senior Statistical Programmer to join our dynamic team. Job SummaryWe are seeking a highly skilled Senior Statistical Programmer with extensive experience in CDISC-compliant statistical programming.

The Statistical

Programmer will act as a subject matter expert (SME) in CDISC data standards and a project manager responsible for coordinating the preparation, execution, reporting and documentation of statistical programming activities internally and externally. This role requires deep expertise in CDISC-compliant programming, thorough understanding of regulatory submission requirements of data packages, and the ability to act as programming project lead across internal and external teams. Key ResponsibilitiesLead and contribute to the development, review, and documentation of CDISC-compliant dataset specifications and data sets, with primary focus on SDTM and ADaM; Perform quality control (QC) of CDISC dataset specifications, derived datasets, and standard or custom tables, figures, and listings (TFLs) to ensure quality and compliance with CDISC standards and regulatory guidelines.

Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. xml, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG), and other documentation as required (e.g., SAS macro libraries, code or documentation templates, standard operating procedures (SOPs)),



development of a modern programming ecosystem (e.g., R adoption, automation, AI integration), and internal training development and delivery to build a consistent, scalable internal CDISC programming infrastructure. Provide technical support to other team members to ensure that they have the required knowledge to fulfil their duties. Work collaboratively with statisticians and/or Data Management function to resolve all data issues arising and to document outcomes.

Maintain quality and timeliness of project work.

Qualifications & ExperienceMaster's degree in Statistics, Biostatistics, Data Science, or a related quantitative field with 6+ years of experience; or Bachelor's degree in the same fields with 8+ years of experience, in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry, with demonstrable hands‐on regulatory submission workExpert‐level proficiency in CDISC‐compliant statistical programming in SAS, including development of SDTM and ADaM datasets from raw clinical data, with a strong understanding of CDISC Implementation Guides (SDTMIG, ADaMIG).xml, SDRG, ADRG, TFLs, and submission documentation aligned with FDA and EMA expectations.

experience authoring or contributing to a Study Data Standardization Plan (SDSP) is preferred and a plus. Proven experience in the creation of macro libraries, format catalogs, enhanced visual output displays, training presentations, SOPs, and other documentation.



Excellent organizational, project management, and written and verbal communication skills are required.

Comfortable working across multiple phases of clinical development and able to shift gears quickly. a self‐starter, proactive and results‐oriented with high performance standards. Ability to manage multiple projects and meet deadlines in a fast‐paced environment. Advanced SAS programming skills are required; Strong understanding of clinical trial design, data analysis, and regulatory requirements.

Experience with cross‐study data integration (e.g., Experience with Standard for Exchange of Nonclinical Data (SEND) is a plus.

Experience of working with international teams remotely is a plus.

Experience in management, Agile/scrum‐type experience is a plus. Statistical background or knowledge is a plusWhat Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice. PharmaLex Belgium SAEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‐discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.

📌 Senior Statistical Programmer - CDISC Lead (Madrid)
🏢 Pharmalex
📍 Madrid