Statistical Programmer II Home Based Biometrics

Statistical Programmer II Job Specific

Skills:

• Proficient generating tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.
• Proficient in SAS programming, SAS Base, SAS Macros.
• Ability to adhere to E-Submission Standards, Guidelines and Regulations.
• Mastery of SDTM standards including ability to write specifications.
• Proficient in ADaM standards.
• Proficient with MS Office applications.
• Ability to adhere to ICH, 21
  
  CRF Part 11, and ISO 9001:2000 requirements.
• Experience with pooling of data sets for submissions.
• Experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
• Member of project team.

• Masters required for all Statistics roles.
• Minimum of 3 years’ experience in Statistical Programming or similar field required.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem‑solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.