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
Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
Skills Required
- Bachelor’s degree in computer science, data science, mathematics, or statistics
- 9+ years of experience as a statistical programmer in a biotech or pharmaceutical clinical development biometrics team, or similar environment
- Experience supporting drug development, medical device development, or intervention studies
- Exceptional SAS and R programming skills in a clinical development environment
- Applied experience with CDISC standards, including SDTM, ADaM, and Define.xml
- Knowledge of medical terminology and clinical trial methodologies
- Knowledge of FDA and ICH regulations
- Experience supporting regulatory submissions and interacting with FDA or global regulatory authorities
- Ability to work independently with minimal supervision
- Outstanding written and verbal communication skills
- Strong leadership skills
- Experience with Python, Java, Shiny, Markdown, Unix/Linux, or Git
Cytel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.
-
Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
-
Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
-
Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.
Cytel Insights
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
