Biostatistician

2 weeks ago

Bengaluru, Karnataka, India Trigent Software Inc Full time

Title: BiostatisticianLocation: Bangalore/Chennai/TrivandrumDuration: Full-timeExperience: 8 YearsJob Description:Study Design and Protocol Development: Collaborate with clinical researchers to designrobust and innovative studies. Develop statistical methodologies and contribute to the creationof study protocols.Data Analysis: Perform complex statistical analyses using appropriate methodologies. Ensurethe 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 andguidelines. Prepare statistical sections of regulatory submissions.Collaboration and Communication: Work closely with cross-functional teams including clinicalresearchers, data managers, and regulatory affairs. Effectively communicate statistical conceptsto non-statistical audiences.Mentorship and Leadership: Provide guidance and mentorship to junior biostatisticians andother team members. Lead statistical training sessions and workshops.Software and Tools: Utilize statistical software such as SAS, R, or other relevant tools toconduct analyses. Stay updated with the latest statistical software and methodologies.Requirements:○ Work Experience: 8 years of work experience in a programming role is preferred. A focus on supporting clinical trials is a significant advantage.○ 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.○ 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.

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