Principal Statistical Programmer FSP
United States
Cytel
At Cytel, our mission is to unlock the power of data, empowering life science leaders to realise the full potential of therapies. Learn more.
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 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.
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 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 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 and other Health Autority 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
- 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
- Prior work experience with pharmacokinetic data and the neuroscience field,
- proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Job stats:
0
0
0
Tags: Biostatistics CDISC Computer Science Git Java Linux Mathematics Pharma Python R SAS Statistics XML
Region:
North America
Country:
United States
More jobs like this
Explore more career opportunities
Find even more open roles below ordered by popularity of job title or skills/products/technologies used.
Data Engineer II jobsSr. Data Engineer jobsBI Developer jobsBusiness Intelligence Developer jobsPrincipal Data Engineer jobsStaff Data Scientist jobsStaff Machine Learning Engineer jobsPrincipal Software Engineer jobsJunior Data Analyst jobsData Science Intern jobsDevOps Engineer jobsData Manager jobsSoftware Engineer II jobsData Science Manager jobsStaff Software Engineer jobsData Analyst Intern jobsLead Data Analyst jobsData Specialist jobsBusiness Data Analyst jobsAI/ML Engineer jobsSr. Data Scientist jobsBusiness Intelligence Analyst jobsData Governance Analyst jobsData Engineer III jobsSenior Backend Engineer jobs
Consulting jobsMLOps jobsAirflow jobsOpen Source jobsEconomics jobsLinux jobsKPIs jobsKafka jobsGitHub jobsTerraform jobsJavaScript jobsPostgreSQL jobsRDBMS jobsData Warehousing jobsPrompt engineering jobsNoSQL jobsStreaming jobsClassification jobsComputer Vision jobsBanking jobsRAG jobsScikit-learn jobsPhysics jobsGoogle Cloud jobsHadoop jobs
dbt jobsPandas jobsGPT jobsBigQuery jobsLooker jobsOracle jobsScala jobsR&D jobsData warehouse jobsReact jobsDistributed Systems jobsLangChain jobsScrum jobsPySpark jobsMicroservices jobsCX jobsELT jobsIndustrial jobsOpenAI jobsSAS jobsRedshift jobsJira jobsModel training jobsTypeScript jobsRobotics jobs