- Data Analysis: Collaborate with cross-functional teams to perform data analysis for phase I to IV clinical studies. Implement statistical programming solutions to support these studies effectively.

- Data Review: Review electronic Case Report Forms (eCRF) and engage in discussions about data structures.

- Ensure that data review activities adhere to company, department, and industry standards (e.g., CDISC).

- Professionalism and Training: Maintain a high level of professionalism, performance, productivity, and quality.

Undergo

Regulatory trainings, including ICH GCP and 21 CFR Part 11 trainings, to stay updated with industry standards.

- Study Documents and Training: Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.).

Complete Project Specific

Trainings and maintain appropriate documentation.

- Data Annotation and Review: Annotate eCRF using Dataset specifications and create annotated CRF (aCRF). Review CRF annotations for protocol compliance and data consistency.

- Programming and Data Management: Develop user-specific Edit check programs to ensure data quality. Identify and document data issues through appropriate trackers and report to the Lead Programmer. Develop SAS programs/macros, templates, and utilities for data cleaning and reporting when necessary.

Perform

Reconciliation of External data.

- Dataset Development: Develop CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications.

Create Annotated

Mock shells if required. Develop tables, listings, and graphs using Mock shells.

- Quality Control and Compliance: Be responsible for all Statistical Programming activities,



including Self-Validation checklists. Ensure that all tabulation/analysis datasets are compliant with CDISC/client standards. Verify the compliance of all programs with SOPs and project-specific guidelines.

Perform First Time Quality

Control on reports created.

- Communication and Collaboration: Provide SAS programming support for Data Management when required. Communicate effectively with the Lead Programmer regarding daily assigned tasks and study-related questions. Maintain explicit and proactive communication with project teams to clarify requirements and specifications.

- Mentorship and Development: Support junior programmers working on the project and assist in their training requirements. Actively engage in self-learning and development in department-specific skill sets.

- Regulatory Compliance and Audits: Support/assist in audit-specific requirements for internal/external audits. Ensure that all activities are performed in accordance with GCP-ICH guidelines.

- Other Responsibilities: Contribute to process improvement initiatives. Provide advanced technical expertise and work under minimal supervision to support various programming activities. Forecast work for the team and provide a vision of ongoing project objectives/milestones. Perform other duties as assigned by the Line Manager/HOD.

- All your contributions will be carried out in strict accordance with GCP-ICH guidelines, reaffirming our commitment to quality and regulatory compliance in every endeavour.

Requirements

Educational Background: Bachelor's, Master's, or international equivalent degree in statistics, computer science, mathematics, life sciences, or a related field.

📌 Statistical Programmer (Bengaluru)
🏢 Oryxion Solutions
📍 Bengaluru