Senior Statistical Programmer II (Remote)

Vertex Pharmaceuticals Incorporated; Boston, Auburn (MA, ME); Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Statistical Programmer II to provide technical guidance on clinical project teams. This role involves designing and developing SAS programs for analyzing clinical data, ensuring compliance with CDISC standards. You will lead quality control efforts and resolve reporting issues while collaborating with a dynamic team. If you have a strong background in SAS programming and clinical trials, this opportunity offers a chance to contribute to innovative projects in a supportive environment.

Qualifications

• 2+ years of experience in Biotech, Pharmaceuticals, or Clinical Research Organizations.
• Proficient in SAS programming for clinical data analysis.

Responsibilities

• Design and code complex SAS programs for clinical trial data analysis.
• Perform quality control checks on SAS code and outputs.

Skills

SAS Programming

CDISC Standards

Clinical Trials Processes

Communication Skills

Education

Bachelor's Degree in Scientific Discipline

Master's Degree in Scientific Discipline

Tools

SAS/STAT

SAS/GRAPH

Electronic Data Capture (EDC)

Interactive Web Response Systems (IWRS)

Job description

Job Description

General Summary:

The Senior Statistical Programmer II provides technical guidance on clinical project teams. The role involves designing, developing, and performing quality control on SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. Additionally, the Senior Statistical Programmer II participates in departmental and cross-functional technology development and process improvement initiatives.

Key Duties and Responsibilities:

1. Codes complex SAS programs (including Macro language, SAS/STAT, and SAS/GRAPH) for analyzing and reporting complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM format, ensuring study objectives are met.
2. Performs quality control checks of SAS code and output produced by other Statistical Programmers.
3. Demonstrates proficient knowledge of clinical development and medical data.
4. Resolves clinical trial reporting problems with proven technical proficiency, supporting daily operations, and ensuring accurate completion of project tasks with limited supervision.
5. Creates CDISC data sets by transforming raw data from various sources, including Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), and reports and submits clinical trial results.
6. Works with coding dictionaries such as MedDRA and WHODD used in the pharmaceutical industry.
7. Provides technical leadership within a team environment, solving clinical trial reporting problems within budget and timeline constraints while maintaining high quality standards.

Knowledge and Skills:

• Proficiency with SAS
• Working knowledge of CDISC standards
• Understanding of clinical trials processes
• Effective written and verbal communication skills for complex information exchange

Education and Experience:

• Bachelor's or Master's degree in a Scientific Discipline
• Typically requires 2+ years of experience for M.S. or above, and 5+ years for B.S., in Biotech, Pharmaceuticals, or Clinical Research Organizations.