- Study Design and Protocol Development: Collaborate with clinical researchers to design robust and innovative studies. Develop statistical methodologies and contribute to the creation of study protocols.

- Data Analysis: Perform complex statistical analyses using appropriate methodologies. Ensure the accuracy and integrity of data.

- Reporting and Interpretation: Prepare detailed reports and present findings to stakeholders. Provide statistical insights to inform decision-making processes.

- Regulatory Compliance: Ensure all statistical practices comply with regulatory standards and guidelines. Prepare statistical sections of regulatory submissions.

- Collaboration and Communication: Work closely with cross-functional teams including clinical researchers, data managers, and regulatory affairs. Effectively communicate statistical concepts to non-statistical audiences.

- Mentorship and Leadership: Provide guidance and mentorship to junior biostatisticians and other team members. Lead statistical training sessions and workshops.

- Software and Tools: Utilize statistical software such as SAS, R, or other relevant tools to conduct analyses. Stay updated with the latest statistical software and methodologies.

Requirements

- Work Experience: 2+ years of work experience in a programming role is preferred. A focus on supporting clinical trials is a significant advantage.

- Statistical Leadership and Support: Provide comprehensive statistical support for clinical studies, including designing study protocols, calculating sample sizes, randomizing patients,



reviewing case report forms (CRFs), conducting statistical analyses, interpreting data, and reporting results.

- Coordination of Analytical Activities: Coordinate the development of analysis plans, table shells, programming specifications, data reviews, statistical analyses, and the creation of tables, listings, and figures.

- Development of Analytical Documents: Develop statistical analysis plans, programming specifications, and mock shells for statistical tables, figures, and data listings for clinical summary reports.

- Collaboration and Implementation: Collaborate closely with the Lead Biostatisticians and Lead Programmer to create and implement project quality control (QC) plans and timelines.

- CRF Design Assistance: Assist Biostatisticians with the statistical aspects of case report form design.

- Quality Control: Perform QC checks on derived datasets, tables, figures, and data listings produced by other team members.

- Training and Me​ntorship: Train and mentor new or junior statisticians on statistical models and methodologies.

- Report Writing and Review:



Write and review the statistical sections of integrated reports and provide input into clinical study reports (CSRs) and other summary reports.

- Leadership in Studies: Act as the statistical team lead for complex studies or a group of studies, providing guidance and oversight.

- Preparation of Reports: Prepare Statistical Analysis Reports (SARs) and contribute to the review of CSRs and other summary documents.

Benefits

- Flexible Work Arrangements: We understand the importance of work-life balance and offer flexible work arrangements to accommodate your needs.

- Professional Development: Continuous learning opportunities and support for professional development to help you stay ahead in your career.

- Collaborative Work Environment: Join a dynamic and collaborative team where your ideas are valued, and teamwork is encouraged.

- Employee Assistance Program (EAP): Access to counseling and support services for personal and professional challenges.

- Recognition and Rewards: Regular recognition programs to celebrate achievements and milestones.

- Work from home Options: Take advantage of our remote work options, providing flexibility and convenience.

- Inclusive and Diverse Workplace: Oryxion is committed to providing an inclusive and diverse workplace where everyone's contributions are valued.

- Opportunities for Advancement: Career growth opportunities within the company as we believe in promoting from within.

- Work on Innovative Projects: Contribute to innovative projects, pushing the boundaries of what's possible.

📌 Biostatistician I (Bengaluru)
🏢 Oryxion Solutions
📍 Bengaluru