As a Principal Statistical Programmer, your responsibilities will include:
- 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 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 programs’ needs
- Participate in overseeing CRO’s 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
- Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes 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, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
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 on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
- Proficient in programming using analytical software such as SAS and R
- Extensive Oncology experience and in-depth knowledge
- Hands-on experience across the full spectrum of statistical programming activities, including but not limited to:
- SDTM and ADaM specification creation and review
- SDTM and ADaM dataset development
- TLF programming
- Define.xml and reviewer’s guide creation
- Skilled in developing macros tailored to project needs
- Demonstrated ability to work independently with minimal supervision from study or asset leads
- Strong sense of ownership and accountability for assigned tasks
- Effective communicator who proactively engages with the team
- Capable of offering process improvement suggestions to the study team
Active participation in programming team meetings and collaborative discussions
Additional Preferences:
- Prior experience working in a global team environment
- Familiarity with CDISC standards and regulatory submission requirements
- Experience supporting FDA, EMA, and PMDA submissions
- Ability to manage multiple studies simultaneously
- Strong documentation and organizational skills
Skills Required
- Bachelor’s degree in computer science, data science, mathematics, or a related field; statistics preferred
- 8+ years of statistical programming experience on a biotech or pharmaceutical clinical development biometrics team, or similar experience supporting drug, medical device, or intervention studies
- Proficiency programming with SAS and R
- Extensive oncology experience and in-depth oncology knowledge
- Experience creating and reviewing SDTM and ADaM specifications
- Experience developing SDTM and ADaM datasets
- Experience programming tables, listings, and figures
- Experience creating Define.xml files and reviewer’s guides
- Experience developing project-specific programming macros
- Ability to work independently with minimal supervision
- Strong ownership, accountability, communication, documentation, and organizational skills
- Ability to proactively collaborate and contribute process improvements
- Prior experience working in a global team environment
- Familiarity with CDISC standards and regulatory submission requirements
- Experience supporting FDA, EMA, and PMDA submissions
- Ability to manage multiple studies simultaneously
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
