As a Senior Statistical Programmer, you will perform programming activities for the creation and validation of SDTM (including efficacy SDTMs) as well as ADaM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology. ISS and ADaM knowledge are a must have.
How you will contribute:
- Performing data analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
- Applying your CDISC know-how and proficiency to create and validate safety and efficacy SDTMs;
- Creating and validating pooled analysis datasets (ADaMs), tables, listings, and figures (TLFs);
- Preparing submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21
- Generating complex ad-hoc reports;
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
- Being adaptable and flexible when priorities change.
Qualifications
At least 5 years of relevant statistical programming experience in a clinical development environment.
BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences, or other related scientific subjects.
- Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
- Ability to implement the latest CDISC SDTM standards (production/validation).
Working knowledge with pooled ADaM data such as in an ISS or other pooled studies dataset.
Recent experience with Oncology is required.
- Submissions experience utilizing define.xml and other submission documents such as SDRG or ADRG are required.
Very good oral and written English communication skills.
Skills Required
- At least 5 years of relevant statistical programming experience in clinical development
- BA/BSc or higher in Statistics, Mathematics, Computer Science, Life Sciences, or related field
- Advanced experience with SAS language, procedures, and options including Macro language, BASE SAS, SAS/STAT, SAS/GRAPH
- Ability to implement and validate CDISC SDTM standards, including efficacy SDTMs
- Working knowledge and experience creating pooled ADaM datasets (e.g., for ISS)
- Recent experience with Oncology studies
- Submissions experience (define.xml and submission documents such as SDRG or ADRG) and use of Pinnacle 21
- Very good oral and written English communication skills
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
