Senior Statistical Programmer

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Skills you'll use

What you'll do

• Lead and contribute to the development, review, and documentation of CDISC-compliant dataset specifications and data sets, with primary focus on SDTM and ADaM; serve as an SME for CDISC standards governance.
• 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.
• Generate or review TFLs for clinical study reports and regulatory submissions.
• Perform statistical programming using SAS and R, ensuring compliance with CDISC standards.
• Prepare submission-ready regulatory documentation including Define.xml, Study Data Reviewer’s Guide (SDRG), Analysis Data Reviewer’s Guide (ADRG), and other documentation as required (e.g., ISS/ISE), in alignment with regulatory authority expectations (e.g., FDA, EMA).
• Contribute to process optimization (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.
• Perform any other related activities assigned by the supervisor and participate in task forces/initiatives.
• Validating/debugging the codes written by other team members.

Who can apply

• Master'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 work
• Expert-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).
• Proven experience supporting regulatory submissions (eCTD), including preparation of SDTM/ADaM datasets, Define.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. Ability to work well with a wide range of internal and external stakeholders and build strong partnerships inside and outside the organization.
• Comfortable working across multiple phases of clinical development and able to shift gears quickly. Must be open to change and the unknown with a creative and resourceful nature; 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; proficiency or active development in R is strongly preferred.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Excellent problem-solving skills and attention to detail.

About Cencora

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