Senior Statistical Programmer – CDISC Lead

Description

The company works in pharmaceuticals and biotechnology, offering supply chain support, clinical trial support, and strategic consulting.

This senior statistical programming role centers on CDISC. You will act as the subject matter expert on CDISC standards and lead programming work, coordinating the preparation, execution, reporting, and documentation of statistical programming with internal and external teams.

The role calls for deep CDISC programming expertise and a clear grasp of regulatory requirements for submission data packages.

Responsibilities

• Take the lead, with hands-on input, on writing, reviewing, and documenting CDISC dataset specifications and datasets, mainly SDTM and ADaM.
• Serve as the go-to expert on CDISC standards governance.
• Run quality control on dataset specifications, derived datasets, and standard or custom TFLs (tables, figures, and listings) to confirm CDISC and regulatory compliance.
• Create or check TFLs for clinical study reports and regulatory submissions.
• Program in SAS and R so that outputs follow CDISC standards.
• Produce submission-ready documents such as Define.xml, SDRG, and ADRG, plus other material like ISS/ISE, aligned with FDA and EMA expectations.
• Help improve processes, including SAS macro libraries, templates, and SOPs.
• Help grow the programming setup through R adoption, automation, AI integration, and internal training, building a consistent and scalable CDISC programming infrastructure.
• Support colleagues so they have the knowledge their work requires.
• Work with statisticians and or data management to resolve data issues as they come up and record the outcomes.
• Check and debug code written by other team members.
• Keep project work on quality and on schedule.
• Take on other related tasks from your supervisor and join task forces or initiatives.

Requirements

• A Master's degree in statistics, biostatistics, data science, or a related quantitative field, plus 6+ years of clinical statistical programming in pharma, biotech, or CRO settings, including hands-on regulatory submission work; or a Bachelor's degree in those fields plus 8+ years of the same experience.
• Expert-level CDISC programming in SAS, building SDTM and ADaM datasets from raw clinical data, with strong knowledge of SDTMIG and ADaMIG.
• Proven record supporting eCTD submissions, including SDTM and ADaM datasets, Define.xml, SDRG, ADRG, TFLs, and submission documents that meet FDA and EMA expectations.
• Proven experience building macro libraries, format catalogs, enhanced visual displays, training presentations, SOPs, and other documentation.
• Strong organization, project management, and written and verbal communication skills. You work well with a wide range of internal and external stakeholders and build lasting partnerships.
• Able to shift quickly across clinical development phases. Open to change and uncertainty, creative, resourceful, self-driven, proactive, and results-focused with high standards.
• Able to manage several projects at once and meet deadlines.
• Advanced SAS programming skills.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Strong problem-solving skills and attention to detail.
• Clear communication and interpersonal skills, with the ability to guide diverse groups through complex processes as a team.
• Strongly preferred: proficiency in R or active R development.
• Preferred: experience authoring or contributing to a Study Data Standardization Plan (SDSP).
• Preferred, a strong plus: primary authorship of an SDSP, SDRG, or ADRG beyond execution-level contribution.
• Preferred, a strong plus: cross-study data integration, such as ISS/ISE.
• Preferred, a plus: experience with Standard for Exchange of Nonclinical Data (SEND).
• Preferred, a plus: remote work with international teams.
• Preferred, a plus: management experience or Agile/Scrum experience.
• Preferred, a plus: statistical background or knowledge.

Conditions

Full-time position.

Benefits

• Benefits outside the US vary by country and follow local market practice.
• Eligibility and effective dates for some benefits may differ, including for team members covered by collective bargaining agreements.