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 position reports to the Engagement lead 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 mainly oncology therapeutic area. A majority of the programmer’s work is hands-on statistical programming and should be keeping the track of the study deliverables for high quality deliverables in time. This position is responsible for keeping all documents updated, assignments of the tasks. Work is to be performed in a team environment, where team members may be distributed globally.
As a Principal Statistical Programmer, your responsibilities will include:
- Meetings and communications
- Generate SDTM and ADaM specifications
- Generate & QC assigned dataset domains
- Support submission activities
- Generate TLFs (patient profile, interim analysis, annual summary report, final CSR)
- Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s)
- Handling Data transfers to sponsor (or other designee)
- Publication support
- Ad hoc tasks/activities requested by sponsor
- Writing SAS macros and other utilities and tools
- Reviewing documents/specifications/output created by sponsor’s Partner CROs
- Maintenance of associated tracking and validation documentation
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
- 8+ years of experience as a Statistical Programmer in clinical Development environment
- Excellent SAS 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
- Prior working experience with Oncology studies
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills
Skills Required
- Bachelor's degree in computer science, data science, mathematics, or statistics
- 8+ years experience as a Statistical Programmer in a clinical development environment
- Excellent SAS programming skills, including writing SAS macros
- Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml)
- Knowledge of medical terminology, clinical trial methodologies, and FDA/ICH regulations
- Experience supporting regulatory submissions and interacting with regulatory authorities
- Prior experience with Oncology studies
- Strong written/verbal communication and leadership skills; ability to work independently
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.
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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.
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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.
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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
