Senior Statistical Programmer

Location: London

Reporting to: Executive Director Biostatistics

The Senior Statistical Programmer at Orchard Therapeutics is a key member of a Biostatistics team working to provide transformative gene therapies to patients. Reporting to the Executive Director Biostatistics, this role provides a unique opportunity to use your programming skills in the production of data analyses from all phases of clinical drug development.

Key Elements and Responsibilities

In this role you will be expected to perform programming activities across multiple studies or projects to deliver datasets and statistical outputs to agreed timelines and quality. This will be a hands-on role in which you will be expected to produce both datasets and outputs.

Key responsibilities will include:
• Writing SAS programs to create analysis datasets, tables, listings, and figures.
• Adhere to CDISC standards for data management and analysis, including SDTM (Study Data Tabulation Model) and ADaM (ADAM Data Model).
• Deliver all required outputs to agreed timelines and quality, (e.g., analysis datasets, pooled datasets, tables, figures and listings for regulatory or reimbursement submissions and publications).
• Participate in the design and/or review of statistical programming deliverables including developing programming specifications for datasets and data outputs.
• Participate in the review of other biometrics deliverables (e.g., case report forms, study database structure, data management and data quality plans, statistical analysis plans).
• Oversight of statistical programming tasks outsourced to CROs, ensuring that their performance meets the agreed quality.

Requirements

Required Knowledge
• 3+ years of experience in clinical trial SAS programming.
• Demonstrated knowledge of and experience in applying CDISC standards.
• Self-starter with the ability to work within a Biostatistics team.

Skills and Abilities
• Proficiency with SAS programming and SAS macro code development required along with a good understanding of SAS GRAPH and SAS ODS.
• Understanding of clinical trial data and terminology.
• Strong attention to detail and accuracy.
• Excellent written and verbal communication skills.
• Experience working with cross-functional groups.
• Ability to manage multiple priorities and work effectively under pressure.
• Knowledge of R would be an advantage.

Education
• BSc or higher in mathematics, statistics, computer science or related discipline.