Senior SAS Programmer

Advanced Clinical; Woodcliff Lake (NJ); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading company is seeking a remote Senior SAS Programmer to lead the development and validation of SDTM datasets for clinical trials. This role involves collaboration with cross-functional teams to ensure compliance and accuracy of clinical trial data, impacting the larger clinical industry. Ideal candidates will have extensive experience in statistical programming within the pharmaceutical sector.

Qualifications

• Minimum of 8 years of experience in Statistical & Clinical programming.
• Proven experience in preparing SDTM datasets for regulatory filings.

Responsibilities

• Lead the development and implementation of submission-ready SDTM datasets.
• Perform thorough quality control checks to validate datasets.

Skills

Statistical Programming

Clinical Programming

Communication

Attention to Detail

Education

Bachelor's or Master's degree in Computer Science, Biostatistics, Life Sciences

Tools

SAS

R

Windows

UNIX

Medidata Rave

Oracle Clinical

Jreview

Spotfire

Tableau

Job description

We are currently searching for a skilled professional to join a well-known client’s team as a remote Senior SAS Programmer. The Sr. SAS Programmer will be responsible for leveraging their extensive experience and expertise to lead the development, implementation, and validation of SDTM (Study Data Tabulation Model) datasets for clinical trials. They will collaborate closely with cross-functional teams, including biostatisticians, data managers, and clinical research associates, to ensure the accuracy, completeness, and compliance of clinical trial data. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA).
• Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards.
• Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.
• Coordinate the preparation and documentation of submission packages, including data specifications and validation documentation.
• Serve as a subject matter expert on submission-related matters, providing guidance and support to cross-functional teams.
• Stay abreast of evolving regulatory requirements and industry best practices related to SDTM and submission standards.

QUALIFICATIONS & EDUCATION

• Bachelor's or Master's degree in a relevant field (e.g., Computer Science, Biostatistics, Life Sciences).
• Minimum of 8 years of experience in Statistical & Clinical programming, with a focus on submission expertise, within the pharmaceutical or biotechnology industry.
• Proficiency in programming languages such as SAS and R.
• Strong knowledge in Windows and UNIX environment, with proficiency in SAS / Base, SAS Macros, SAS / Graph, SAS / SQL, SAS Grid, SAS Enterprise Guide, CDISC, SDTM, MedDRA, WHO DRUG;
• Deep understanding of CDISC standards and regulatory submission requirements.
• Proven experience in preparing and submitting SDTM datasets for regulatory filings (e.g., IND, NDA, BLA).
• Excellent communication and collaboration skills, with the ability to work effectively in a cross-functional environment.
• Strong attention to detail and a commitment to ensuring the quality and integrity of submission datasets.
• Experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and other tools (Jreview, Spotfire, Tableau) is a plus.
• Experience with Oncology and Neuroscience Therapeutic areas is plus

About Advanced Clinical

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Senior Programmer • Woodcliff Lake, NJ, US