At Cytel, we believe in empowering our employees for success through consistent training, development, and support. As a Principal Statistical Programmer, you'll be fully embedded within one of our global pharmaceutical clients, a company at the forefront of patient treatment innovation. This is an exciting opportunity to work with autonomy and ownership, driving the next generation of therapies within a new program.
This position reports to the Director, Biostatistics and Programming in Cytel's FSP Services business unit. You'll work independently with minimal supervision, track progress, and provide expert technical support to your team. We're looking for a highly experienced senior statistical programmer who will contribute to clinical development programs across various therapeutic areas and oversee CRO programmers to ensure consistent, high-quality data summaries. You will be responsible for implementing all reporting and analysis activities for the Sponsor's clinical trials.
Key Responsibilities
As a Principal Statistical Programmer, your responsibilities will include:
- Generate SDTM, ADaM specifications, datasets, reviewer's guides, and define.xml files for multiple studies.
- Develop SAS programs to generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.
- Deliver high-quality statistical programming results, including developing, validating, and maintaining SAS and/or R programs tailored to clinical development program needs.
- Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high quality and adherence to pre-specified timelines.
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSURs, 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 the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
- Participate in the 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 (e.g., CROs, software vendors, clinical development partners) to ensure project timelines and goals are met.
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.
Qualifications
To be successful in this position, you will have:
- At a minimum, a 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 with a similar team, with experience supporting drug development, medical device development, or intervention studies.
- Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment.
- Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
- Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities.
- Must be able to work independently.
- Outstanding communication skills (written and verbal) and strong leadership skills.
Preferred Qualifications (nice to have)
- Prior work experience with pharmacokinetic data and in the neuroscience field.
- Proficiency in languages or tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, and Git).
