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Manager, Csar - Sas Edit Check Programmer

9-13 years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: MBA/BCS/BBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Manager, CSAR – SAS Edit Check Programmer

Location: Hyderabad, India
Work Location Type: On Site
Job ID: R-211020
Date Posted: April 16, 2025
Category: Information Systems


About the Role:

Amgen is seeking a highly capable Manager, CSAR – SAS Edit Check Programmer to join their team, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. This role is centered on supporting SAS edit check programming activities, focusing on the creation and implementation of edit checks in line with Amgen’s standards, procedures, and best practices.

The Manager will work closely with CSAR Operations and cross-functional teams to ensure the delivery of high-quality clinical systems outputs and to support electronic data capture (EDC) technologies. The position holds responsibility for ensuring quality and deliverables at the study and portfolio levels and contributing to large-scale system transformation initiatives through subject matter expertise, stakeholder engagement, project management, and change management.

The successful candidate will demonstrate strong leadership skills with the ability to influence stakeholders and will also serve as an individual contributor on study-specific and broader CSAR/Global Development Operations projects.


Roles & Responsibilities:

  • Provide programming support for clinical trial platform technologies.

  • Support decision-making by offering analytical insights and identifying patterns in data.

  • Coordinate and provide SAS programming support to Clinical Study Teams.

  • Collaborate closely with Clinical Data Management teams to achieve study deliverables and timelines.

  • Serve as a technical point of contact for system deliverables across assigned programs.

  • Design, develop, and program complex SAS edit checks based on specifications; conduct thorough testing to ensure functionality and preempt potential issues.

  • Provide technical and business process expertise for emerging technologies.

  • Develop, review, and implement policies, SOPs, and associated documentation.

  • Assist with audit preparations and responses (internal and external).


Required Knowledge and Skills:

  • Knowledge of Good Clinical Practice (GCP).

  • Strong understanding and application of performance management techniques, problem-solving, and analytical thinking.

  • In-depth knowledge of drug development and clinical trial processes.

  • Proficient understanding of data management processes.

  • Expertise in SAS edit check programming.

  • Experience with programming clinical trial databases and applications.

  • Familiarity with the systems development lifecycle.

  • Strong project planning and management skills.

  • Ability to collaborate effectively with global cross-functional and matrix teams.

  • Knowledge of quality management and risk analysis.

  • Understanding of regulatory filings and inspections.

  • Exposure to process improvement methodologies.


Preferred Qualifications:

  • Advanced degree or equivalent in life sciences, computer science, mathematics, statistics, business administration, or a related discipline with 9–13 years of experience.

  • Broad work experience in data management/programming within the pharmaceutical or biotech sectors.

  • Proven experience in managing teams.

  • General project management and planning experience.

  • Experience in oversight of external vendors (CROs, central labs, imaging vendors, IRT vendors, etc.).


Basic Qualifications:

  • Bachelor’s degree or equivalent in life sciences, computer science, business administration, or a related discipline with 9–13 years of relevant experience.

  • Proven experience in managing teams.

  • Specialist knowledge or experience in life sciences or a medically related field.

  • General biopharmaceutical clinical research experience, gained through working on clinical trials at a biotech, pharmaceutical, or CRO company.