Lead Statistical Programmer - Bios2
London, England, United Kingdom
The Lead Statistical Programmer at Orchard Therapeutics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Director Biostatistics, this role provides a unique opportunity to use your SAS programming skills in the production of data analyses from all phases of clinical drug development.
In this role you will be expected to provide leadership and guidance as the lead statistical programmer on one or more projects. You will be required to plan and manage 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 both to produce datasets and outputs and to manage CROs providing this service.
Key responsibilities will include:
- Plan and manage programming activities to 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).
- Management and oversight of statistical programming tasks outsourced to CROs, ensuring that their performance meets the agreed timelines, quality and budget requirements established for the project or study.
- 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).
- Act as key statistical programming contact for internal project team and external project partners.
- Mentoring and development of less senior programming staff
- Other activities as may be assigned
Demonstrable leadership, project management, and interpersonal skills
Experience working as a SAS programmer, preferably in a drug development environment
Experience in managing and working with CROs and consultants in outsourcing statistical programming work
Good knowledge of and experience in applying CDISC standards
Self-starter with the ability to work on a cross-functional team
Education & skills
- BSc or higher in mathematics, statistics, computer science or related discipline
- Experience working as a SAS programmer, preferably in a drug development environment
- Proficiency with SAS programming and SAS macro code development required along with a good understanding of SAS GRAPH and SAS ODS.
- Demonstrated knowledge of and experience in the application of CDISC standards (SDTM and ADaM)
- Knowledge of non-SAS programming packages an advantage (e.g. Spotfire, S-Plus, R)
- Excellent written and verbal communication skills
- Proven leadership skills