SAS Programmer/Developer With 7 yrs. working experience with Pharma Industry required

SAS Programmer/Developer With 7 yrs. working experience with Pharma Industry required

Posted 5 days ago by 1756181134

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Negotiable
Outside
Remote
USA
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Data Analysis Extensible Markup Language (XML) Generic Programming Input/Output Management Microsoft Office Process Improvement SAS (Software) Software Development

Summary: The role of SAS Programmer/Developer requires a professional with over 7 years of experience in the pharmaceutical industry, focusing on programming and problem resolution in SAS. The position involves providing comprehensive programming support for clinical trials, ensuring compliance with regulatory requirements, and managing project deliverables. The candidate must possess advanced knowledge of CDISC and ICH guidelines related to drug development. This is a remote position based in the USA, classified as outside IR35.

Key Responsibilities:

  • Provide comprehensive programming support, including development of programs and ADaM specifications.
  • Manage and deliver assignments with quality and within timelines.
  • Provide programming support to CDISC based e-submission and enhance SAS programs for quality control.
  • Implement programming standards and communicate project status to management.
  • Standardize GSD deliverables across study projects and identify process improvement opportunities.
  • Proactively communicate issues impacting programming deliverables with team members.

Key Skills:

  • Expert level programming skills in SAS.
  • Strong knowledge of ADaM and submission experience.
  • Advanced understanding of government regulations (CDISC, ICH).
  • Solid statistical knowledge and experience in clinical trials.
  • Proficient in using SAS for analysis datasets and TLGs.
  • Ability to work independently and in a team environment.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: IT

Detailed Description From Employer:

Job Role: SAS Programmer/Developer With 7+ years Pharma Experience Required

Location: Remote in USA

Contract C2C/W2

Core essential:
1. Expert level of programming skills and problem resolution in SAS.
2. Strong knowledge of Adam (all apecs-related)
3. Submission experience (required)
4. Advanced knowledge of government regulations (such as CDISC and ICH guidelines)
5. pertaining to drug development in multiple therapeutic areas.
6. Tackles difficult problems; Identifies solutions and help leading decisions to resolve
Manage and deliver assignments with quality and within timelines by being independ and proactive
7. Solid Statistical Knowledge
8. 7+ years of relevant Pharma experience recommended

Essential Duties & Responsibilities:
1. Primarily works at the study, product / program level
2. Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices.
3. Manages and Delivers assignments with good quality and within timelines
4. 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.
5. 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.
6. 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
7. Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Experience Required:

  • Bachelors + 7 year, 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.
    Experience Preferred:
    Specialized or Technical Knowledge Licenses, Certifications needed:

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.
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