SAS Programmer

SGS Consulting; Elm (PA); On-site; USD 120,000 - 150,000; Full time

Job summary

SGS Consulting is seeking a senior programmer in pharma/clinical research to lead programming at the study and program level, delivering high-quality work.

You will develop SAS programs, ADaM specifications, and analyses (datasets, TLGs) in compliance with CDISC, ICH, and regulatory requirements, supporting e-submissions.

This role requires strong SDTM/ADaM knowledge, experience with Pinnacle 21, XML, MS Office, and the ability to work independently within teams to meet timelines.

Qualifications

• Bachelor’s or Master’s degree in science, statistics, IT, or equivalent combination of education and related work experience.
• 7+ years of professional Pharma/programming experience in a pharmaceutical or clinical research setting.
• Proficient knowledge of SDTM, ADaM standards and Implementation guides.
• Strong understanding of CDISC-based e-submission (ADaM datasets and TLGs) and eSUB components.
• Experience producing analysis datasets, TLGs, and regulatory submissions.
• Demonstrated ability to work independently and in a team environment.

Responsibilities

• Primarily works at the study, product or program level.
• Develops SAS programs, ADaM specifications, and analyses (datasets, TLGs) compliant with regulatory requirements and SOPs.
• Manages and delivers assignments with high quality within timelines.
• Supports CDISC-based e-submission; develops, debugs, and enhances SAS programs for quality control of safety or efficacy datasets and TLGs.
• Implements programming standards and ensures regulatory compliance across projects; communicates project status and gaps to management.
• Standardizes GSD deliverables (datasets and TLGs) across study projects and suggests process improvements.
• Proactively communicates issues impacting programming deliverables with Statistics or DM teams.

Skills

SAS programming

ADaM knowledge

CDISC submission experience

CDISC/ICH regulatory knowledge

Problem solving

Project delivery & time management

Statistical knowledge

Pharma experience 7+ years

Education

Bachelor’s or Master’s degree in science

Pharmaceutical/clinical research programmer experience

Tools

Pinnacle 21

XML

MS Office

Job description

Job Responsibilities:

• Primarily works at the study, product / program level
• Provides 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 timelines
• Provides 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 improvement
• Proactively 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 resolve
• Manage and deliver assignments with quality and within timelines by being independent and proactive
• Solid Statistical Knowledge
• 07+ 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.