Senior Statistical Programmer - CDISC Lead

myhrabc; España; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Cencora is seeking a highly skilled Senior Statistical Programmer with extensive CDISC-compliant statistical programming expertise. The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and coordinate programming activities for regulatory submissions.

You will develop SDTM/ADaM datasets, prepare Define.xml, SDRG, ADRG, and support SDSP development while collaborating with statisticians and data management across internal and external teams.

Formación

• Master's or Bachelor's degree in a quantitative field with significant clinical programming experience.
• Hands-on regulatory submission experience (eCTD) with SDTM/ADaM.
• Experience creating macro libraries, documentation, and SOPs.

Responsabilidades

• Lead development and documentation of CDISC datasets (SDTM/ADaM) and act as SME on CDISC standards.
• QC CDISC datasets, tables, figures and listings for regulatory quality.
• Prepare submission-ready documentation (Define.xml, SDRG, ADRG) per FDA/EMA expectations.
• Collaborate with statisticians and data management to resolve data issues.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Project management

Communication skills

Educación

Master's degree in Statistics/Biostatistics/Data Science

6+ years clinical statistical programming experience

Herramientas

SAS

R

Descripción del empleo

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Job Title: Senior Statistical Programmer (CDISC focus)

Location: Spain, Portugal or Poland

Job Type: Full-Time

Company Overview

Cencora is a leading organization in the pharmaceutical/biotechnology industry, dedicated to advancing healthcare through innovative research and development. 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 Summary

We 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 Responsibilities

• 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.


• Maintain quality and timeliness of project work.

Qualifications & Experience

• 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; proficie