Statistical Programmer

Roles and responsibilities

Key Responsibilities and Qualifications for a SAS Programmer in Clinical Data Analysis

As a SAS Programmer specializing in clinical data analysis, you will play a crucial role in ensuring the integrity and quality of data in clinical trials. Your primary responsibilities will include designing and developing SAS programs that adhere to regulatory standards, such as CDISC, SDTM, and ADaM. You will work closely with cross-functional teams, including statisticians and clinical experts, to prepare Statistical Analysis Plans (SAPs) and ensure that the resulting data outputs meet the highest standards of quality and accuracy.

A significant portion of your work will involve generating tables, listings, and figures (TLFs) that summarize clinical trial data. These outputs are critical for regulatory submissions and scientific publications. In addition to generating TLFs, you will be responsible for validating datasets, ensuring that the data is consistent, complete, and meets the specifications outlined in the SAP.

You will also play an important role in troubleshooting and improving existing programming processes. By identifying inefficiencies or areas for improvement, you will help streamline workflows and enhance the overall productivity of the team. This might involve developing more efficient programming solutions, automating repetitive tasks, or refining processes to ensure that deadlines are met without sacrificing quality.

To stay current in the field, it will be essential for you to maintain up-to-date knowledge of industry standards and regulatory requirements. This includes staying informed about changes to CDISC standards, new FDA or EMA guidelines, and best practices in clinical data programming.

Desired candidate profile

Required Qualifications

To be successful in this role, you will need a Bachelor’s degree in a relevant field such as Statistics, Computer Science, or a closely related discipline. A strong academic background will provide the foundation for understanding complex statistical analyses and data management processes.

Proficiency in SAS programming is essential, with hands-on experience in BASE SAS, SAS MACRO, and SAS STAT. You should have a solid understanding of CDISC standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), as these are central to clinical trial data management and analysis. A background in a pharmaceutical, biotechnology, or Contract Research Organization (CRO) environment is highly preferred, as it demonstrates familiarity with the regulatory and operational nuances of clinical trials.

Attention to detail is a key trait for this position. You will need to ensure that data is accurate, complete, and properly formatted for regulatory submission. In addition, strong organizational and communication skills are essential for collaborating with different departments, handling multiple projects simultaneously, and ensuring that all deliverables are submitted on time.