Note: The job is a remote job and is open to candidates in USA. Cytel is seeking a Principal Statistical Programmer to work fully embedded with a pharmaceutical client on clinical development programs across therapeutic areas. The role independently leads statistical programming activities, oversees deliverables, supports regulatory submissions, and provides technical leadership while developing and validating SAS and R programs.
Responsibilities
- Generating SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
- Understand and follow FDA regulations which affect the reporting of clinical trial data, with experience supporting multiple FDA submissions across a broad range of programming activities
- Lead and support the development of SAS programs to generate datasets, complex listings, tables, and complex graphs
- Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
- Participate in overseeing statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Provide review and/or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
Skills
- At a minimum bachelor's degree in computer science, data science, mathematics, or statistics major preferred
- 9+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
- Exceptional SAS/R programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
- A drive to support immediate delivery demands while helping the organization adopt new technologies, standards, and ways of working
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills
- Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
Benefits
- Full-time employment
- Consistent training, development and support
- Remote work arrangement
Company Overview
Company H1B Sponsorship