Principal Stat Programmer at Midsized CRO
Follow current SDTM standards and current ADaM Implementation Guides 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.
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 update SAS/R programs to adapt to various study situations and perform self-review to ensure outputs are as expected.
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
Interact with other staff members to understand and explain SAS programs accurately.
Collaborate CROs, software vendors, clinical development partners to ensure meeting project timelines and goals
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 etc.
Experience supporting drug development, medical device development, or intervention studies.
Exceptional SAS programming skills
Extensive experience with CDISC standards (SDTM, ADaM), medical terminology, clinical trial methodologies, and FDA regulation
Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities.
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 (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)