Senior Principal, Statistical Programming (SAS/R)

Location: Remote/Home-Based in Cambridge or London, UK.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on neuroscience and oncology.

What you will do

• Lead statistical programming across complex Phase I–IV clinical trials and multi-study programs from study startup through final CSR and regulatory filing.
• Author, review, and finalize SAPs, dataset specifications, and TFL mock shells with Biostatistics and Clinical Science teams.
• Architect, program, validate, and troubleshoot CDISC SDTM and ADaM datasets, statistical tables, figures, and listings.
• Prepare ISS/ISE analyses and electronic submission deliverables, including Define.xml, SDRG/ADRG documentation, and Pinnacle 21 validation reports.
• Oversee CRO and FSP programming deliverables, timelines, data transfers, quality assurance, and milestone coordination.
• Develop reusable SAS macros, R functions, automation scripts, and standardized TFL templates while mentoring statistical programmers.

Requirements

• At least 8 years of statistical programming experience in pharmaceutical, biotechnology, or CRO environments, or 6+ years with an advanced degree.
• Expert-level SAS proficiency, including Base, Stat, Macro, ODS, and Graph, plus working knowledge of R or Python in a validated clinical environment.
• Mastery of CDISC SDTM and ADaM, Define.xml generation, and Pinnacle 21 validation tools.
• Hands-on experience authoring submission-level deliverables, including ISS/ISE, SDRG/ADRG, and support for an NDA, BLA, or MAA submission.
• Experience serving as the primary study or program lead programmer for multiple early- or late-stage clinical studies.
• Ability to resolve complex programming logic challenges, design efficient algorithms, and optimize heavy data workflows.
• Strong collaboration skills with Biostatistics, Data Management, Medical Monitoring, and Regulatory Operations.
• Knowledge of ICH/GCP, 21 CFR Part 11, computer systems validation, and clinical reporting procedures.
• Bachelor’s, Master’s, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.

Nice to have

• Direct experience supporting a major NDA, BLA, or MAA filing or a complex integrated ISS/ISE analysis.

Culture & Benefits

• Remote/Home-Based work arrangement in the UK.
• Work within a global, patient-focused and science-driven biopharmaceutical organization.
• Collaborate across internal functions and external CRO and FSP teams.
• Equal opportunity and affirmative action employer.