Leads statistical programming for pharmaceutical clinical development studies, generating SDTM and ADaM datasets, specifications, tables, listings, graphs, and regulatory documentation. Develops, validates, and maintains SAS and R programs; supports FDA submissions, clinical study reports, DSURs, publications, and data transfers. Oversees programming deliverables, maintains standards and macros, collaborates with CROs and vendors, and provides technical leadership and mentorship.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will forge a long term relationship with the client, starting with study level programming responsibilities before building into leadership positions. The successful candidate will show proven leadership through technical expertise and has the ability to share knowledge and inspire others. Experience with R and an openness to learning and adopting new technologies will support the position.
As a Principal Statistical Programmer, your responsibilities will include:
- 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
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- 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
Preferred Qualifications (nice to have)
Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
Cytel Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
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