Senior Principal, Statistical Programming

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the Lead Statistical Programmer for intricate Phase I–IV clinical trials or multi-study project areas.

• Take responsibility for programming deliverables from the initiation of the study through to the final Clinical Study Report (CSR) and filing.

• Create, review, and finalize Statistical Analysis Plans, dataset specifications, and mock shells for tables, figures, and listings (TFL).

• Manage study-level programming schedules, resource management, and strategies for risk mitigation.

• Design, program, and validate datasets compliant with CDISC standards, including SDTM and ADaM.

• Develop, validate, and troubleshoot statistical tables, figures, and listings using SAS, R, and contemporary programming tools.

• Oversee the preparation and compilation of electronic submission datasets and supporting documentation, such as Define.xml, SDRG/ADRG, and Pinnacle 21 validation reports.

• Prepare integrated summaries of safety and efficacy (ISS/ISE) for global regulatory submissions and expedited inquiries.

• Provide technical oversight and ensure quality assurance for programming deliverables from external CROs and Functional Service Providers (FSPs).

• Evaluate CRO specifications, raw data mappings, analysis datasets, and TFLs.

• Coordinate data transfers and milestones between internal cross-functional teams and external programming teams.

• Design, validate, and maintain SAS macros, R functions, automation scripts, and standardized TFL templates.

• Assess and pilot new technologies, automated pipelines, and open-source statistical computing tools.

• Mentor and guide junior and mid-level statistical programmers through code reviews, best practices, and technical troubleshooting.

⛳️ Requirements

• Demonstrated expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) along with data manipulation techniques.

• Proven experience or working knowledge of R/Python within a validated clinical setting.

• Extensive understanding of CDISC SDTM and ADaM models, Define.xml creation, and Pinnacle 21 validation tools.

• Hands-on experience in authoring submission-level deliverables, including ISS/ISE integration and SDRG/ADRG documentation.

• Direct experience in supporting an NDA, BLA, or MAA submission.

• Proven capability to address complex programming logic problems, design efficient data algorithms, and enhance heavy data workflows.

• Excellent communication skills with the ability to collaborate with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations staff.

• Comprehensive knowledge of ICH/GCP guidelines, 21 CFR Part 11, principles of computer systems validation (CSV), and standard operating procedures related to clinical reporting.

• A Bachelor's, Master's, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a similar quantitative field.

• A minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO sectors (or 6+ years with an advanced degree).

• Proven history of serving as the lead programmer for multiple clinical studies across both early- and late-stage development.

• Direct experience in supporting at least one significant regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is highly preferred.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Retirement savings plan.

• Flexible paid vacation.