Senior Statistical Programmer

MMS Holdings; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a skilled SAS Programmer to join their team. In this pivotal role, you will leverage your expertise in SAS programming to generate critical data presentations for clinical trials. Your responsibilities will include mastering the generation of tables, listings, and graphs, as well as supporting drug development projects. This role offers the opportunity to engage with cross-functional teams and contribute to service enhancements while ensuring high-quality deliverables. If you have a passion for data and a desire to make an impact in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• 5-9 years of programming experience in drug development.
• Strong SAS programming skills and understanding of CDISC standards.

Responsibilities

• Generate tables and graphs from clinical trial databases using SAS.
• Lead programming project teams and manage tasks independently.

Skills

SAS Programming

SDTM Standards

ADaM Standards

Clinical Trial Knowledge

Data Presentation Skills

Communication Skills

Problem Solving

Project Management

Education

Bachelor's Degree in Computer Science

Master's Degree in Computer Science

Tools

SAS Base

SAS Macros

MS Office

Job description

Responsibilities:

1. Mastery in generating tables, listings, and graphs from clinical trial databases using SAS.
2. Utilizes System Development Life Cycle (SDLC) for programming deliverables.
3. Advanced user in SAS programming, SAS Base, and SAS Macros. Knowledge of E-Submission Standards, Guidelines, and Regulations.
4. Train on SDTM standards including writing specifications.
5. Support ADaM standards including specification writing.
6. Proficient with MS Office applications.
7. Knowledge of ICH, 21CRF Part 11, ISO 9001:2000 requirements.
8. Experience with pooling data sets for submissions.
9. Experience with BIMO outputs, define.xml, Reviewers Guides, SDSP.
10. Lead study or small programming project teams.
11. Manage tasks and projects independently, guiding junior colleagues.
12. Identify opportunities for improvement and contribute to service enhancements.
13. Engage with customers, support Business Development activities.
14. Apply theoretical knowledge practically, analyze problems, and determine solutions.
15. Stay updated on industry and technology developments, diagnose gaps, and propose solutions.
16. Maintain confidentiality and exercise judgment regarding information disclosure.
17. Solve complex problems, produce high-quality deliverables, and represent the company professionally.
18. Practice excellent customer service, communication, and teamwork.
19. Support departmental and organizational objectives and improvements.
20. Comply with policies, procedures, and training requirements.
21. Perform additional tasks as assigned.

Minimum Requirements:

1. College degree in computer science or related field; Masters preferred.
2. 5-9 years of programming experience, with interest in drug development.
3. High-level knowledge of drug development related to clinical programming.
4. Experience with clinical trials and pharmaceutical development.
5. Experience with data and production of TLGs.
6. Strong programming and logic skills.
7. Understanding of CDISC and HL-7 standards.
8. Experience in pharmaceutical or CRO industry.
9. Strong SAS programming skills, including SAS Base and Macros.
10. Knowledge of clinical database structures.
11. Ability to program data presentations with SAS procedures.
12. Excellent organizational and communication skills.