Senior Statistical Programmer

Summary

Join MMS, a leading data-focused clinical research organization (CRO), and contribute to a supportive, innovative team. As a Senior Statistical Programmer, you will play a crucial role in generating tables, listings, and graphs from clinical trial databases using SAS. You will utilize the System Development Life Cycle (SDLC) for programming deliverables and possess advanced knowledge of E-Submission Standards, Guidelines, and Regulations. This role requires a Master's degree in Statistics and at least 5 years of experience in Statistical Programming or a similar field. You will be responsible for leading study or small programming project teams and ensuring compliance with industry standards and regulations.

Requirements

• Advanced user in SAS programming, SAS Base, and SAS Macros
• Advanced knowledge of E-Submission Standards, Guidelines and Regulations
• Advanced knowledge of ADaM standards including supporting specification writing
• Proficient with MS Office applications
• Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements
• Advanced experience with pooling of data sets for submissions
• Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP
• Masters required for all Statistics roles
• Minimum of 5 years’ experience in Statistical Programming or similar field required
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• Proficiency with MS Office applications
• 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
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process

Responsibilities

• Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SAS
• Utilizes System Development Life Cycle (SDLC) for programming deliverables
• Mastery and trained on SDTM standards including ability to write specifications
• Lead study or small programming project teams

Preferred Qualifications

• Hands-on experience with clinical trial and pharmaceutical development preferred
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements