As a Principal Statistical Programmer, your responsibilities will include:
- Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
- Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
- Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations
- Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with significant consequences and impact
- Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers
- Performs review on define.xml and create reviewers guide for SDTM and/or ADaM datasets
- Review, maintain study documents per standard process
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Perform other duties as assigned
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:
- MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry,
- 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 of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
- Must be able to work independently
- Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
- Outstanding communication skills (written and verbal) and strong leadership skills
- Excellent and transparent communication skills and ability to influence across multiple functions
- Experience with BLAs, MAAs and other regulatory submissions is a plus
Skills Required
- MS in biostatistics or related field with 8 or more years of pharmaceutical industry experience, or BS in biostatistics or related field with 10 or more years of pharmaceutical industry experience
- Exceptional SAS programming skills in a clinical development environment
- Extensive experience with CDISC standards, including SDTM, ADaM, and Define.xml
- Knowledge of medical terminology and clinical trial methodologies
- Expertise in SAS language, procedures, options, Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
- Experience supporting regulatory submissions and interacting with FDA or global regulatory authorities
- Ability to work independently with minimal supervision
- Highly developed written, oral presentation, communication, and leadership skills
- Ability to influence across multiple functions
- Experience with BLAs, MAAs, and other regulatory submissions
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
