Lead statistical programming for sponsor clinical trials: create SDTM/ADaM specs and datasets, develop/validate SAS and R programs, produce tables/listings/figures, oversee CRO programming deliverables, support regulatory submissions and study reports, and maintain programming standards, documentation, and SOPs.
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 Senior/Principal Statistical Programmer, your responsibilities will include:
- Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
- Develop SAS/R 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
- 5+ 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
- 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
#LI-KO1
Similar Jobs
Cloud • Information Technology • Security • Software • Cybersecurity
The role involves driving revenue growth through enterprise-level sales, managing customer engagements, and leading virtual teams. Requires deep tech knowledge and negotiation skills.
Top Skills:
Cloud NetworkingEdge ComputingGoogle SuiteMsft SuiteSalesforceSecurityTableau
Artificial Intelligence • Cloud • Security • Software • Cybersecurity
Serve as Datadog expert for partner channel: onboard, train, and enable partner technical teams; support migrations, modernization, demos, proofs of value; advocate partner technical needs internally; collaborate with product, engineering, and partners to drive adoption and prioritize features.
Top Skills:
Alibaba CloudAnsibleApmAppdynamicsAWSAzureChefCloud FoundryDatadogDockerDynatraceGCPGitlabGoJavaScriptJenkinsKubernetesLogsNew RelicNpmOpenshiftPerlPHPPuppetPythonRubySplunkSyntheticsTerraform
Artificial Intelligence • Consumer Web • Digital Media • Information Technology • Social Impact • Software
As the Lead Product Designer for Discover, you'll design AI-driven experiences for a two-sided marketplace while mentoring the design team and owning the product design direction.
Top Skills:
Ai-Assisted Prototyping Tools (CursorClaude CodeFigmaLovable)V0
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
