Senior Report Programmer

Job Title: Senior Report Programmer

• Design, develop, validate, and maintain

  global standard and study-specific clinical data review reports

  using

  SAS

  ,

  SQL

  , and

  visualization platforms

  (JReview, Spotfire, Power BI, etc.).
• Create

  patient profiles

  ,

  safety review dashboards

  ,

  data listings

  , and

  summary reports

  to support clinical teams.
• Develop reusable

  macros

  ,

  templates

  , and

  scripts

  to ensure consistency and efficiency across studies.
• Automate report generation and distribution processes wherever feasible.

2

• Extract, transform, and integrate data from multiple clinical data sources including

  Rave EDC

  ,

  eCOA

  ,

  biomarker

  , and

  external lab data

  .
• Write complex

  SQL queries

  and

  SAS programs

  to combine and structure data for reporting needs.
• Ensure data accuracy, completeness, and traceability throughout the reporting process.

3

• Perform

  rigorous QC and peer reviews

  of reports and programming outputs.
• Maintain compliance with

  regulatory requirements

  (GCP, CDISC, 21 CFR Part 11).
• Ensure alignment with internal

  data standards

  ,

  naming conventions

  , and

  reporting templates

  .

4£

• Collaborate with

  Clinical Data Management

  and

  Biostatistics

  to understand study-specific data review needs.
• Translate reporting requirements into

  technical specifications

  , data flow diagrams, and validation plans.
• Document all report logic, assumptions, and design decisions in accordance with

  SOPs and audit requirements

  .

5£

• Deploy and manage reports on

  global reporting platforms

  (e.g., JReview, Spotfire server).
• Maintain version control, access permissions, and refresh schedules for live dashboards.
• Provide post-deployment support, enhancements, and troubleshooting as required.

6£

• Partner with

  Data Managers, Biostatisticians, Programmers, and Clinical Operations

  teams to deliver end-to-end reporting solutions.
• Mentor junior report programmers and contribute to the development of

  best practices

  ,

  reporting standards

  , and

  automation initiatives

  .
• Participate in cross-functional working groups focused on

  data quality improvement

  and

  reporting efficiency

  .

Required Qualifications

• Education:

  Bachelors or Masters degree in Computer Science, Life Sciences, Statistics, or related field.

• Experience:

  Minimum

  6+ years

  in clinical reporting, programming, or analytics within the

  pharma, CRO, or biotech

  industry.

• Technical Skills:

• Advanced programming expertise in

  SAS

  and

  SQL

  .
• Experience with

  data visualization/reporting tools

  : JReview, Spotfire, Power BI, Tableau, or Qlik.
• Familiarity with

  Rave EDC

  and other clinical data systems.
• Understanding of

  CDISC standards (SDTM/ADaM)

  and

  clinical data structures

  .

• Soft Skills:

• Strong analytical thinking and problem-solving skills.
• Excellent communication and documentation abilities.
• Ability to manage multiple studies and priorities independently.

Preferred Qualifications

• Experience in

  global clinical reporting standardization

  initiatives.
• Exposure to

  Python or R

  for data analytics or automation.
• Familiarity with

  data warehousing concepts

  or

  ETL processes

  .
• Experience working in a

  regulated environment

  (GxP / 21 CFR Part 11).
• Knowledge of

  drug development lifecycle

  and

  clinical trial processes

  .

Key Competencies

• Attention to detail and commitment to data accuracy.
• Proactive and solution-oriented mindset.
• Collaborative team player with leadership potential.
• Strong time management and accountability for deliverables.

Performance Indicators (KPIs)

• On-time delivery of validated reports.
• Accuracy and quality of data outputs.
• Adherence to coding standards and SOPs.
• Stakeholder satisfaction with reporting solutions.
• Contribution to process automation and improvement.