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Principal Statistical Programmer
Clinical Outcomes SolutionsSenior Statistical Programmer dedicated to a global pharmaceutical company's innovation. Working on clinical development programs with minimal supervision.
Tech Stack
Tools & technologiesJavaLinuxPythonUnix
About the role
Key responsibilities & impact- Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you
- 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
- Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
- Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
- Develop SAS programs which generate datasets, complex listings, tables 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 pre-specified timelines
Requirements
What you’ll need- 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 (preferred)
- Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git) (preferred)
Benefits
Comp & perks- Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
- We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful.
ATS Keywords
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Hard Skills & Tools
SASRPythonJavaShinyMarkdownUnix/LinuxCDISC standardsstatistical programmingdata analysis
Soft Skills
communication skillsleadership skillsindependenceteam supportproblem-solving