Senior Statistical Programmer - Lead SDTM/ADaM

Cytel; Annapolis (MD); On-site; USD 140,000 - 210,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, driving high-quality SDTM/ADaM deliverables and regulatory submissions. You will lead SAS/R programming efforts across studies, mentor teammates, and ensure timelines and standards are met.

You will navigate FDA regulations, develop and validate programming solutions, and collaborate with CROs and vendors to maintain execution excellence in a fast-paced environment.

Qualifications

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
• 9+ 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/R 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
• A drive to support immediate delivery demands while helping the organization adopt new technologies, standards, and ways of working.
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills
• Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Responsibilities

• Generating SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Understand and follow FDA regulations which affect the reporting of clinical trial data, with experience supporting multiple FDA submissions across a broad range of programming activities
• Lead and support the development of SAS programs to 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 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
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• 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

Skills

SAS programming

R programming

Leadership

Communication skills

CDISC standards

FDA submissions

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

SAS

R

Unix/Linux

Git

Shiny

Python

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, driving high-quality SDTM/ADaM deliverables and regulatory submissions. You will lead SAS/R programming efforts across studies, mentor teammates, and ensure timelines and standards are met.

You will navigate FDA regulations, develop and validate programming solutions, and collaborate with CROs and vendors to maintain execution excellence in a fast-paced environment.