Senior Statistical Programmer – CDISC Lead

PharmaLex; Warszawa; On-site; PLN 230,000 - 320,000; Full time

Job summary

Cencora is seeking a Senior Statistical Programmer with CDISC expertise to lead regulatory data packages and SDTM/ADaM development across cross-functional teams.

The role emphasizes SAS and R programming, CDISC standards governance, and preparation of Define.xml, SDRG, ADRG for FDA/EMA submissions, with remote collaboration across international teams.

You will drive process improvements, support data management, and help train staff in modern programming practices.

Qualifications

• 6+ years in clinical statistical programming with regulatory submission experience.
• Expert-level SAS with SDTM/ADaM development from raw data.
• Experience with eCTD submissions and regulatory expectations.
• Strong communication and project management skills.
• Ability to lead CDISC governance and training initiatives.

Responsibilities

• Lead SDTM and ADaM dataset development and data set specifications.
• QC CDISC datasets and TFLs for regulatory submission.
• Prepare Define.xml, SDRG, ADRG and other submission documents.
• Perform statistical programming in SAS and R for CDISC datasets.
• Collaborate with statisticians and data management across teams.

Skills

CDISC programming

SAS programming

R programming

Project management

Documentation skills

Quality assurance

Education

Master's degree in Statistics

Bachelor’s degree in related field

Tools

SAS

R

Job description

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; 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.
• Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment.

Preferred Qualifications

• Experience with SDSP, SDRG, or ADRG as primary author beyond execution‑level contribution is a strong plus.
• Experience with cross‑study data integration (e.g., in ISS/ISE) is a strong plus.
• 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 plus.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Affiliated Companies: PharmaLex Belgium SA

Equal Employment Opportunity

Cencora 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. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request‑by‑request basis. Messages and emails regarding anything other than accommodations requests will not be returned