Remote Senior Statistical Programmer

• We generate tables, listings, and graphs from clinical trial databases using SAS.
• We use the System Development Life Cycle (SDLC) for programming deliverables.
• We write specifications for SDTM deliverables.
• We support specification writing for ADaM deliverables.
• We lead study teams or small programming project teams.

Technologies:

• GCP
• Support
• SAS
• XML
• Cloud
• DevOps
• HTTP

• We require a Masters degree for all Statistics roles.
• We require a minimum of 5 years experience in Statistical Programming or a similar field.
• We expect advanced knowledge of SAS programming, SAS Base, and SAS Macros.
• We expect advanced knowledge of e-submission standards, guidelines, and regulations.
• We expect mastery of SDTM standards, including the ability to write specifications.
• We expect advanced knowledge of ADaM standards, including support for specification writing.
• We expect advanced knowledge of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.
• We expect advanced experience with pooling datasets for submissions.
• We expect advanced experience with BIMO outputs, define.xml, Reviewers Guides, and SDSP.
• We expect proficiency with MS Office applications.
• We expect expert knowledge of scientific principles and concepts.
• We value hands-on experience with clinical trials and pharmaceutical development.
• We expect strong communication skills and the willingness to work collaboratively to understand needs and solve problems.
• We expect excellent problem-solving skills.
• We expect strong organizational skills.
• We value familiarity with current ISO 9001 and ISO 27001 standards.
• We expect familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• We expect a basic understanding of CROs, scientific and clinical data terminology, and the drug development process.
• We look for candidates with a reputation as an emerging leader in the field with sustained performance and accomplishment.