Senior Statistical Programmer – CDISC Lead

This is a fully remote position, open to applicants in Spain, +2 more countries.

📋 Description

• Lead the development, review, and documentation of dataset specifications and datasets that comply with CDISC standards, with an emphasis on SDTM and ADaM.

• Act as a subject matter expert in the governance of CDISC standards.

• Conduct quality control checks on CDISC dataset specifications, derived datasets, and both standard and custom TFLs.

• Create or review TFLs for clinical study reports and regulatory submissions.

• Execute statistical programming using SAS and R.

• Prepare regulatory documentation that is ready for submission, including Define.xml, SDRG, ADRG, ISS/ISE, and related materials.

• Contribute to process improvements, SAS macro libraries, code and documentation templates, SOPs, R adoption, automation, AI integration, and the development of training materials.

• Offer technical support and training to team members.

• Collaborate with statisticians and Data Management to address and document data-related issues.

• Engage in task forces and initiatives.

• Validate and troubleshoot code produced by other team members.

• Oversee the preparation, execution, reporting, and documentation of statistical programming activities both internally and externally.

• Ensure project quality and adherence to timelines.

⛳️ Requirements

• A Master's degree in Statistics, Biostatistics, Data Science, or a related quantitative field with over 6 years of experience; or a Bachelor's degree in the same fields with over 8 years of experience.

• More than 6 years of clinical statistical programming experience with a Master's degree, or over 8 years with a Bachelor's degree, within the pharmaceutical, biotechnology, or CRO sectors.

• Proven experience in regulatory submission work.

• Expertise in CDISC-compliant statistical programming using SAS.

• Experience in developing SDTM and ADaM datasets from raw clinical data.

• Strong knowledge of CDISC Implementation Guides (SDTMIG, ADaMIG).

• Experience in supporting eCTD regulatory submissions, including SDTM/ADaM datasets, Define.xml, SDRG, ADRG, TFLs, and submission documentation that meets FDA and EMA standards.

• Experience in creating macro libraries, format catalogs, enhanced visual output displays, training presentations, SOPs, and other documentation.

• Exceptional organizational, project management, written, and verbal communication skills.

• Ability to collaborate with internal and external stakeholders and build effective partnerships.

• Comfortable working across various phases of clinical development.

• Capability to manage multiple projects and meet deadlines in a dynamic environment.

• Advanced skills in SAS programming.

• Proficiency or active development experience in R is highly preferred.

• Strong understanding of clinical trial design, data analysis, and regulatory requirements.

• Outstanding problem-solving abilities and meticulous attention to detail.

• Strong communication and interpersonal skills, with the capacity to guide diverse teams through complex processes.

• Preference for experience as the primary author of SDSP, SDRG, or ADRG beyond execution-level contributions.

• Preferred experience with cross-study data integration, SEND, international remote teams, management, Agile/scrum methodologies, or a statistical background.

🏝️ Benefits

• Benefit offerings outside the US may differ by country and will align with local market practices.

• Equal employment opportunities and support for reasonable accommodations.