Overview
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
This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.
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 senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.
This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
Responsibilities
- Generate SDTM, ADaM specifications, datasets, reviewer’s guide and Define.xml files for multiple studies
- Develop SAS programs which generate datasets, complex listings, tables (including descriptive and standard inferential statistics) 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
- Oversee CROs’ statistical programming deliverables for multiple clinical studies to ensure high-quality work and meet pre-specified timelines
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
- Understand and follow FDA regulations affecting the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions
- Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Assist in development of CRFs, edit check specifications, and data validation plans
- Provide review and/or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (CROs, software vendors, clinical development partners) to meet project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Qualifications
- Bachelor’s degree in computer science, data science, mathematics, or statistics (major preferred)
- 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
- Exceptional SAS programming skills and expertise in statistical programming procedures in a clinical development environment
- Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations
- Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities
- Experience in oncology studies using RECIST 1.1
- Ability to work independently
- Strong written and verbal communication skills and leadership
Preferred Qualifications
- Prior work with pharmacokinetic data and the neuroscience field
- Proficiency in languages or tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, Git)
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
- Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
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