Lead design and implementation of SDTM and ADaM specifications and datasets; develop, validate, and maintain SAS and R programs for tables, listings, figures, and analyses; oversee CRO programmers; support clinical study reports, regulatory submissions, and standards documentation; contribute to CRF, edit check, and SOP development.
Sponsor-dedicated:
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 is an exciting time to be a part of this new program.
Position Overview:
This position reports to the Director, Biostatistics and Programming 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 different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
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
- 7+ 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 programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Experience with hands-on R programming
- 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
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills
Preferred Qualifications (nice to have)
- Prior work experience with pharmacokinetic data and the neuroscience field,
- proficiency in languages or tools other than SAS and R (e.g., Python, and Java, Shiny, Markdown, Unix/Linux and git)
#LI-KO1
Similar Jobs
Cloud • Security • Software • Cybersecurity • Automation
Leads GitLab’s EMEA Customer Success Management and Customer Success Engineering organizations. Sets regional strategy, integrates relationship and technical teams, drives adoption and measurable outcomes, oversees customer health, renewals and expansion support, improves operational performance, and develops distributed leadership teams. Partners cross-functionally with Sales, Product, Engineering, Professional Services, Support, and Marketing to deliver consistent enterprise customer value.
Top Skills:
DevsecopsDuo Agent PlatformGainsightGitlabGitlab DuoSalesforce
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Leads research and production development of generative AI and large language model systems for cybersecurity. Responsibilities include defining AI research strategy, developing novel reasoning and summarization approaches, selecting model architectures and deployment strategies, building large-scale production systems, mentoring scientists, establishing evaluation standards, and guiding cross-functional technical initiatives. The role also represents the company through publications, speaking engagements, and technical thought leadership.
Top Skills:
Cloud TechnologiesDeep LearningGpu TechnologiesLarge Language Models (Llms)Python
Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Lead change management for strategic, transformational, and cross-functional initiatives across the MEU region. Develop change strategies, assess organizational impacts, coordinate communications and training, coach stakeholders, influence senior leaders, and measure adoption and effectiveness. The role operates in a global, matrixed environment and requires strong communication, stakeholder management, change methodology, and instructional design capabilities.
What you need to know about the London Tech Scene
London isn't just a hub for established businesses; it's also a nursery for innovation. Boasting one of the most recognized fintech ecosystems in Europe, attracting billions in investments each year, London's success has made it a go-to destination for startups looking to make their mark. Top U.K. companies like Hoptin, Moneybox and Marshmallow have already made the city their base — yet fintech is just the beginning. From healthtech to renewable energy to cybersecurity and beyond, the city's startups are breaking new ground across a range of industries.
