SAS Programmer

SGS Consulting; Philadelphia (Philadelphia County); On-site; USD 120,000 - 160,000; Full time

Job summary

SGS Consulting seeks an experienced pharmaceutical SAS programmer to support study-level and submission activities. You will develop programs, ADaM datasets, and TLGs in compliance with CDISC and ICH guidelines.

You will work cross-functionally with Statistics and Data Management, ensure quality within timelines, and help standardize deliverables across projects.

Qualifications

• Bachelor’s or master’s degree in science, statistics, IT, or equivalent.
• 7+ years of professional pharma/clinical research programming experience.
• Expert SAS programming skills and strong problem-solving abilities.
• In-depth ADaM and CDISC knowledge with submission experience.
• Advanced understanding of CDISC/ICH regulations for drug development.
• Proficient in creating datasets, TLGs, and eSub components using SAS.
• Ability to work independently and in a team.

Responsibilities

• Provide comprehensive SAS programming support from study level to submission datasets.
• Develop, debug, and enhance SAS programs ensuring QA and regulatory compliance.
• Standardize GSD deliverables across studies and therapeutic areas.
• Collaborate with Stat/DM teams and communicate project status.
• Ensure timely delivery of analyses, datasets, and TLGs.
• Utilize tools like Pinnacle 21, XML, and MS Office as needed.

Skills

SAS programming

ADaM knowledge

CDISC submissions

Regulatory knowledge CDISC/ICH

Statistical analysis knowledge

Problem solving

Project independence

Education

Bachelor’s or Master in science/statistics/IT

Tools

Pinnacle 21

XML

MS Office

Job description

Job Responsibilities:

Primarily works at the study, product / program levelProvides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices.Manage and Delivers assignments with good quality and within timelinesProvides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs.Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.Responsible for the standardization of GSD deliverables (datasets and associated TLGs) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvementProactively communicates issues impacting programming deliverables with Stat or DM team members.

Skills:

Expert level of programming skills and problem resolution in SAS.Strong knowledge of Adam (all aspects-related)Submission experience (required)Advanced knowledge of government regulations (such as CDISC and ICH guidelines) pertaining to drug development in multiple therapeutic areas.Tackles difficult problems; Identifies solutions and help leading decisions to resolveManage and deliver assignments with quality and within timelines by being independent and proactiveSolid Statistical Knowledge07+ years of relevant Pharma experience recommended

Education/Experience:

Education Required: Bachelor’s Degree/ Master’s degree in science, Statistics, Information Technology or equivalent combination of education and related work experience.

Experience Required: Bachelors + 7 years, Masters + 6 years of professional experience in a pharmaceutical or clinical research setting as a programmer.Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.Strong understanding of SDTM, ADaM standards and Implementation guides.Demonstrated proficiency in using SAS to produce analysis datasets, TLGs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)Demonstrated ability to work independently and in a team environment.Functional Knowledge: Expert level of programming skills and problem resolution in SAS.Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspection deliverables).Have solid knowledge of statistical models used for efficacy data analysis.Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.