215 Biostatistics Jobs - Page 6

Position Summary The Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaning Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 5 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary The Central Monitor II will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor II may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: support monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary The Principal Central Monitor serves as a strategic leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM). This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders. Operating at the highest level of subject matter expertise, the Principal Central Monitor oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios. This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement. In addition to managing escalations and complex data review activities, the Principal Central Monitor mentors senior & junior colleagues, contributes to global process innovation, and plays a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities organizationally. Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Advanced Centralized Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks. Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance, in collaboration with functional team leads and PM RBQM Meetings: Lead facilitation monthly RBQM meetings, bringing together key stakeholders to review and discuss study data, findings, action plans and coordination of data cleaning activities to support study deliverables. Drive the review of key risk indicators (KRIs), data trends, and issue resolution plans. Provide expert guidance on data cleaning prioritization to meet critical study milestones. Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Mentor teams on proactive data monitoring techniques and lead initiatives to continuously improve data integrity and efficiency. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: lead discussions with Sponsors around risk management and proactive data cleaning Qualifications Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar & scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred CRO experience as a Central Monitor Skills Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Central Monitor II will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor II may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: support monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Qualifications: Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required: Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Preferred: CRO experience as a Central Monitor Skills: Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaning Qualifications: Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 5 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required: Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred: CRO experience as a Central Monitor Skills: Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Principal Central Monitor serves as a strategic leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM). This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders. Operating at the highest level of subject matter expertise, the Principal Central Monitor oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios. This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement. In addition to managing escalations and complex data review activities, the Principal Central Monitor mentors senior & junior colleagues, contributes to global process innovation, and plays a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities organizationally. Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Advanced Centralized Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks. Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance, in collaboration with functional team leads and PM RBQM Meetings: Lead facilitation monthly RBQM meetings, bringing together key stakeholders to review and discuss study data, findings, action plans and coordination of data cleaning activities to support study deliverables. Drive the review of key risk indicators (KRIs), data trends, and issue resolution plans. Provide expert guidance on data cleaning prioritization to meet critical study milestones. Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Mentor teams on proactive data monitoring techniques and lead initiatives to continuously improve data integrity and efficiency. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: lead discussions with Sponsors around risk management and proactive data cleaning Qualifications: Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required: Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar & scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred: CRO experience as a Central Monitor Skills: Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Job description We’re Hiring | Research Associate – Computational Oncology & Single-Cell Genomics Project Title: Tumor Grade Progression & Drug Discovery in ccRCC Using Single-Cell Multi-Omics Location: NIT Rourkela, Odisha, India (On-site) Apply by: June 24, 2025 | Interview: Online Type: Full-time | Duration: 3 years Salary: ₹69,600/month (₹8.35 LPA) Join Dr. Akhilesh Mishra’s lab at NIT Rourkela on an ANRF-funded project exploring tumor heterogeneity and novel drug targets using cutting-edge single-cell genomics and computational oncology. What You’ll Do ? Perform NGS data analysis and Single Cell Genomics studies. Collect & classify clinical ccRCC samples with pathologists Who We’re Looking For Required: Ph.D. in Computational Biology, Bioinformatics, Computer Science, or related field OR PG degree + 3 years of experience in NGS/Computational Biology + 1 SCI publication Preferred: Experience with NGS Data Analysis and single-cell genomics Proficiency in biostatistics, data analysis, and biomedical techniques About the Lab Dr. Mishra’s lab works at the intersection of genomics, systems biology, and AI. His work has been featured in PNAS, Journal of Clinical Investigation, European Urology, and Oxford Nucleic Acid Research. This is a dynamic opportunity to grow under strong mentorship while contributing to impactful cancer research. How to Apply: (1) Download and fill the application form below: https://nitrkl.ac.in/docs/Career/ProjectFelow/2023/20072023174608110.pdf (2) Send the filled application form along with CV and list of publications (as one PDF) to: mishraakhilesh@nitrkl.ac.in, akhilesh.bioinfo@gmail.com (3) Mention your email Subject as: Application for RA Position – Advt.- 25LS010 - Your Name No hard copies required. Show more Show less

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About The Role Major accountabilities: Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic. Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner. Provide coordination between the project resources so that deadlines are met on deliverables. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key Performance Indicators Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Minimum Requirements Work Experience: Functional Breadth. Cross Cultural Experience. Managing Crises. Collaborating across boundaries. Operations Management and Execution. Skills Automation. Biostatistics. Clinical Trials. Computer Programming. Metadata Management. Statistical Analysis. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams. About The Role Major accountabilities: Ensuring alignment with the CDS strategy; Responsible for Clinical Data Standard/automation solution planning, definition, development, validation and support Serves as the primary contact for global / TA data standards and/or technologies ensuring timely and quality deliverables. Responsible for driving efficient, high quality and timely implementation of new standards and/or technologies. Ensure efficient governance and approval of global clinical data standards / technologies liaising with governance boards as needed. Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems. Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs. Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent. Key Performance Indicators Timely execution of of projects and data requests; Feedback from project sponsors and key stakeholders Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Work Experience Managing Crises. Functional Breadth. Project Management. Collaborating across boundaries. Representing the organization. Skills Automation. Biostatistics. Clinical Trials. Computer Programming. Cross-Functional Teams. Data Analytics. Decision Making Skills. Metadata Management. Statistical Analysis. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams. About The Role Major accountabilities: Ensuring alignment with the CDS strategy; Responsible for Clinical Data Standard/automation solution planning, definition, development, validation and support Serves as the primary contact for global / TA data standards and/or technologies ensuring timely and quality deliverables. Responsible for driving efficient, high quality and timely implementation of new standards and/or technologies. Ensure efficient governance and approval of global clinical data standards / technologies liaising with governance boards as needed. Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems. Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs. Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent. Key Performance Indicators Timely execution of of projects and data requests; Feedback from project sponsors and key stakeholders Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Work Experience Managing Crises. Functional Breadth. Project Management. Collaborating across boundaries. Representing the organization. Skills Automation. Biostatistics. Clinical Trials. Computer Programming. Cross-Functional Teams. Data Analytics. Decision Making Skills. Metadata Management. Statistical Analysis. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad

Work Schedule Other Environmental Conditions Office At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to be expanding our Medical Writing FSP Team in India. We seeking a PMW dedicated to a client in the FSP space; preferred candidates will have experience in Structured Content Authoring systems and automation to support delivery. The ideal candidate will be experienced and highly skilled, responsible for creating, reviewing, and managing clinical regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely. Key Responsibilities: Lead the development, writing, and editing of complex clinical and regulatory documents. Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents. Ensure documents align with regulatory guidelines, company standards, and industry best practices. Provide strategic input and guidance on document content, structure, and presentation. Mentor and provide oversight to junior medical writers and ensure high-quality deliverables. Manage multiple writing projects simultaneously and prioritize tasks effectively. Stay current with industry trends, guidelines, and regulatory requirements. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years in core Regulatory Medical Writer role capacity). Experience working in the pharmaceutical/CRO industry required. Experience in managing and directing complex medical writing projects required. Extensive experience in Phase 3 CSRs and/or protocol development required. EU CTR experience preferred. Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills. Proven leadership skills to manage and mentor a team of medical writers. Extensive knowledge of regulatory guidelines and drug development processes. Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders. Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards. Self-motivated and adaptable. Excellent judgment; high degree of independence in decision making and problem solving. Capable of mentoring and leading junior level staff. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Show more Show less

We are looking for a highly motivated Associate Data Scientist with an interest in real-world evidence (RWE) and healthcare data analytics to join our growing Bangalore-based RWE analytics team at Clarivate. About You – Experience, Education, Skills, And Accomplishments Bachelor’s or Master’s degree in Data Science/Analytics, Biostatistics, Computer Science, or a related quantitative field At Least 2 years of experience in a data-oriented role, preferably in healthcare analytics (internships count) Strong coding skills in SQL and/or Python, AI/ML , Statistical modelling to efficiently work with large, complex relational healthcare databases Interest in healthcare data and familiarity with standard healthcare coding systems (e.g., ICD, CPT, HCPCS, LOINC, SNOMED, etc.) Strong problem-solving skills and attention to detail Eagerness to learn and contribute in a collaborative, team-based environment It would be great if you also had . . . Exposure to real-world data (e.g., claims, EHR, labs, etc.) Basic understanding of observational research or epidemiological concepts Experience working on academic or professional projects involving healthcare data What will you be doing in this role? Support the team by querying large-scale real-world data sources (claims, EMR, lab, etc.) Assist in preparing client-ready outputs, dashboards, and summary reports Help conduct feasibility assessments for various RWE use cases Document code, data assumptions, and analysis steps to support reproducibility Collaborate with senior analysts, data scientists, and project leads across functions Contribute to internal knowledge sharing, code libraries, and process improvement initiatives About The Team We are a highly motivated team of 20+ analytics, biostatistics, epidemiology, and data science professionals distributed across three countries, working together to provide analytics and insights using Clarivate’s RWD product for pharmaceutical, biopharma, and MedTech clients. Hours of Work Hybrid work mode. You will be expected to work on a work schedule (12:00 PM IST to 9:00 PM IST) to provide for reasonable hours of collaborative work with the US team and there could be a slight extension on an as-needed basis. Location – Bengaluru At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

Job Purpose China and Japan play a critical role in the growth and success of the GSK organization. The creation of Asia Development organization provides an opportunity for the biostatistics team to utilize statistical methods to further enhance our disease understanding and to help determine the optimal analytical methods using appropriate data sources in Asia. This new job description reflects the accountabilities and skill sets required to meet the needs of leading innovation in Asia Development Biostatistics. This new role is created to help shape the future of the Asia Development Biostatistics function and transform the way in which GSK uses data and quantitative thinking to drive disease-aligned decision-making in R&D. This individual will be able to place statistical thinking at the heart of regional and global R&D decision-making; to ensure that the fit-for-purpose statistical methodology, such as predictive models and well-designed experiments and trials, deliver robust evidence as the input to those decisions – ultimately making the R&D process more efficient and increasing the probability of success. Key Responsibilities Enhance our disease understanding through the implementation of advanced statistical and/or machine learning methodologies across a range of areas from complex models through to market access activities involving real world data to directly support business critical projects. Identify opportunities to utilize statistical methods to further enhance our disease understanding. Collaboration with cross regional and global functional quantitative groups to help determine the optimal analytical methods using appropriate data sources. Support the upskilling of Statisticians and other quantitative disciplines in statistical methodologies for disease understanding in Asia including their direct application in clinical development planning. Lead the planning and implementation of strategic projects within Asia Development Biostatistics, ensuring they have clear objectives, achievable timelines, intermediate milestones, and well-defined criteria for success Present statistical principles, methods, study designs, and/or results transparently and precisely to GSK researchers and management across all levels both in Asia and the global organization, ensuring appropriate understanding and contributing to better quantitative decision-making across drug development Interact with external Asia scientific groups (industry, academia, regulators) and vendors through presentations, publications, and collaborations, in order to contribute to innovation and uptake of novel statistical methodology and tools within GSK Asia and across the pharmaceutical industry. Serve as a member of the Asia Development Biostatistics Leadership Team Basic Qualifications PhD in Statistics or closely related field 10+ years experience in the field of drug development 5+ years experience as a people leader Knowledge/understanding of drug development process Preferred Experience Or Qualifications Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change. Demonstrated digital fluency and experience in applying creative thinking/business analysis skills to improve or solve business problems. Experience applying a broad array of foundational statistical methodologies, including but not limited to methods for study/experimental design, linear models, generalized linear models, linear and generalized mixed models, survival analysis, Bayesian methods, longitudinal data analysis, and causal inference. Knowledge of or interest multiple aspects of drug development, including drug discovery, preclinical development, and clinical development Experience working in high performance computing environments either for running intensive computational methods or for handling large simulation experiments Evidence of ability to publish quantitative methodological research or scientific research findings using advanced quantitative methodologies. Demonstrable evidence of influencing and partnering with diverse stakeholders of varying levels of seniority. Managerial experience Good communication and influencing skills, curiosity, passion for patients Knowledge and work experience in clinical statistics. Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making in Asia Development. Demonstrate leadership in the application of innovative approaches with portfolio-level impact. Works to move the Asia Development statistics organization to a leadership position in the industry both regionally and globally. A strong sense of initiative, urgency, drive, pragmatism and judgement – overall an ability to make things happen. Proven ability to deliver to demanding deadlines whilst maintaining the highest quality. Show more Show less

Job Purpose China and Japan play a critical role in the growth and success of the GSK organization. The creation of Asia Development organization provides an opportunity for the integrated and disease-aligned biostatistics team to achieve synergies through collective expertise/capabilities for Asia, in advocating and implementing innovative statistical approach. This new job description reflects renewed accountabilities required to meet the needs in leading biostatistics for a therapeutic area (Vaccine) in Asia. This new role is created with the primary accountability of the therapeutic area oversight and leadership (Vaccine) in Asia Development Biostatistics. This role is expected to strengthen the biostatistics therapeutic knowledge, technical capabilities and execution excellence; and to deliver the biostatistics and programming components on target to meet/exceed the Upper Quartile objective and the accelerate access of innovative medicines and vaccines in Asia. Key Responsibilities Build and manage a high-performing team of statisticians from Japan and China, and manage change with a keen sense of cultural awareness Set and lead the Asia biostatistical strategy and technical expertise in a therapeutic area, including opportunities for innovation and continuous improvement Develop in-depth clinical and statistical knowledge in a specific therapeutic area across assets and countries Partner with the global and regional cross-functional counterparts to understand and align the strategic objectives and ensure high quality execution of all trial analyses and submissions Influence planning and decision-making strategy over a portfolio of assets through building and maintaining effective business relationships with key functions Drive the quantitative decision-making principles/process to inform smart risk-taking drug development in Asia Contribute to and influence the strategic direction of the asset development in Asia and regulatory submission via rigorous and robust statistical knowledge Ensure state-of-the-art expertise on all methodological aspects of drug development in statistics Serve as a member of the Asia Development Biostatistics Leadership Team Represent GSK Asia Development Biostatistics at scientific meetings and proactively engage the external working groups to advocate for and trailblaze statistical methodology with the industry and regulatory agencies Basic Qualifications PhD (preferred) or Master’s Degree in Statistics or closely related field 10+ years experience in the field of drug development 5+ years experience as a people leader Knowledge/understanding of drug development process Preferred Experience Or Qualifications Experience of working as a project lead statistician in a pharmaceutical or biotech company in Asia Experience in regulatory interactions and well versed in regional regulations Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change. Experience in line management of staff. Broad understanding of external landscape with respect to role and its related functions Experience in leading teams and business improvement efforts with positive results. Demonstrated digital fluency and experience in applying creative thinking/business analysis skills to improve or solve business problems. Demonstrated effectiveness in building, managing and leveraging networks/client relationships internally Excellent knowledge of programming languages, SAS and/or R Ability to manage conflicting demands and priorities and to negotiate successfully Effective Project Management skills or relevant experience Demonstrated ability to manage the outsourcing or externalization of statistical tasks Effective written and verbal communication skills Encourages the “one team” spirit in all circumstances to be able to solve technical, expertise or organizational issues Good communication and influencing skills, curiosity, passion for patients Knowledge and work experience in a specific therapeutic area (Vaccine) Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making in Asia Development. Demonstrates leadership in the application of innovative approaches with portfolio-level impact. Works to move the Asia Development statistics organization to a leadership position in the industry both regionally and globally. A strong sense of initiative, urgency, drive, pragmatism and judgement – overall an ability to make things happen. Proven ability to deliver to demanding deadlines whilst maintaining the highest quality. Show more Show less

Job Purpose China and Japan play a critical role in the growth and success of the GSK organization. The creation of Asia Development organization provides an opportunity for the integrated and disease-aligned biostatistics team to achieve synergies through collective expertise/capabilities for Asia, in advocating and implementing innovative statistical approach. This new job description reflects renewed accountabilities required to meet the needs in leading biostatistics for a therapeutic area (RIRU) in Asia. This new role is created with the primary accountability of the therapeutic area oversight and leadership (RIRU) in Asia Development Biostatistics. This role is expected to strengthen the biostatistics therapeutic knowledge, technical capabilities and execution excellence; and to deliver the biostatistics and programming components on target to meet/exceed the Upper Quartile objective and the accelerate access of innovative medicines and vaccines in Asia. Key Responsibilities Build and manage a high-performing team of statisticians from Japan and China, and manage change with a keen sense of cultural awareness Set and lead the Asia biostatistical strategy and technical expertise in a therapeutic area, including opportunities for innovation and continuous improvement Develop in-depth clinical and statistical knowledge in a specific therapeutic area across assets and countries Partner with the global and regional cross-functional counterparts to understand and align the strategic objectives and ensure high quality execution of all trial analyses and submissions Influence planning and decision-making strategy over a portfolio of assets through building and maintaining effective business relationships with key functions Drive the quantitative decision-making principles/process to inform smart risk-taking drug development in Asia Contribute to and influence the strategic direction of the asset development in Asia and regulatory submission via rigorous and robust statistical knowledge Ensure state-of-the-art expertise on all methodological aspects of drug development in statistics Serve as a member of the Asia Development Biostatistics Leadership Team Represent GSK Asia Development Biostatistics at scientific meetings and proactively engage the external working groups to advocate for and trailblaze statistical methodology with the industry and regulatory agencies Basic Qualifications PhD (preferred) or Master’s Degree in Statistics or closely related field 10+ years experience in the field of drug development 5+ years experience as a people leader Knowledge/understanding of drug development process Preferred Experience Or Qualifications Experience of working as a project lead statistician in a pharmaceutical or biotech company in Asia Experience in regulatory interactions and well versed in regional regulations Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change. Experience in line management of staff. Broad understanding of external landscape with respect to role and its related functions Experience in leading teams and business improvement efforts with positive results. Demonstrated digital fluency and experience in applying creative thinking/business analysis skills to improve or solve business problems. Demonstrated effectiveness in building, managing and leveraging networks/client relationships internally Excellent knowledge of programming languages, SAS and/or R Ability to manage conflicting demands and priorities and to negotiate successfully Effective Project Management skills or relevant experience Demonstrated ability to manage the outsourcing or externalization of statistical tasks Effective written and verbal communication skills Encourages the “one team” spirit in all circumstances to be able to solve technical, expertise or organizational issues Good communication and influencing skills, curiosity, passion for patients Knowledge and work experience in a specific therapeutic area (RIRU) Business Acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making in Asia Development. Demonstrates leadership in the application of innovative approaches with portfolio-level impact. Works to move the Asia Development statistics organization to a leadership position in the industry both regionally and globally. A strong sense of initiative, urgency, drive, pragmatism and judgement – overall an ability to make things happen. Proven ability to deliver to demanding deadlines whilst maintaining the highest quality. Show more Show less

Statistician – Biosimilar Phase I Studies NY Metro Area (hybrid) K3-Innovations is seeking a Statistician to lead the design and analysis of biosimilar clinical trials , focusing on Phase I trials including PK/PD equivalence , Bayesian methods , and regulatory strategy . Key Responsibilities: Design and analyze biosimilar Phase I trials (PK/PD, immunogenicity) Apply Bayesian modeling and adaptive design strategies Author SAPs, protocols, and study reports Develop Cutting Edge Trial Designs Present statistical designs and results to the FDA and other agencies Qualifications: Master’s/Ph.D. in Biostatistics or related field 8+ years in clinical trial statistics, including 5+ in biosimilars Expertise in Bayesian methods and equivalence study design Experience presenting at FDA meetings (e.g., Type B, Scientific Advice) Proficiency in R, SAS, Stan, JAGS, or WinBUGS Knowledge of FDA/EMA biosimilar and ICH guidance Show more Show less

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyThe Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Masters in actuarial science

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment. Show more Show less

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment. Show more Show less

Company Description AlzaSyno Life Sciences offers a comprehensive suite of CRO (Contract Research Organization) services tailored to the pharmaceutical, bio-pharmaceutical, medical device, and Ayurvedic sectors. Their key services include Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory Affairs. Role Description This is a full-time on-site role for a Quality Assurance Executive located in Gurgaon. The Quality Assurance Executive will be responsible for implementing and maintaining quality standards, conducting quality audits, and managing quality control processes on a day-to-day basis. Qualifications Quality Control and Quality Assurance skills in Clinical Trial Quality Management and Quality Auditing skills in Clinical Trial Strong attention to detail and analytical skills Knowledge of regulatory requirements and compliance in Clinical Trial Excellent communication and teamwork skills Bachelor's degree in Life Sciences, Chemistry, Biology, or related field Show more Show less

Job Description As a Software Engineer, the person will contribute to the development of product software. Depending upon the project need, the person may develop front- or back-ends of rich, interactive cloud-native apps, interactive dashboards and visualizations for data-intensive scientific apps, rich desktop apps. Responsibilities Study and understand the software requirements and participate actively in requirements discussions. Develop and execute automated unit tests for your code, ensuring adequate code coverage. Address code review comments in a timely manner. Troubleshoot, debug and fix defects in the application. Document code as per the standard process, and support tech leads in your code’s integration with other parts of the application. Identify and list opportunities for code refactoring and share those with your tech leads. Estimate and plan your own work and deliver as per the plan. Work within an Agile Scrum team by collaborating with tech leads, Subject Matter Experts, and other team members. Master relevant software development practices, tools, and technologies. Comply with relevant company policies. Keep knowledge up to date by undergoing appropriate trainings and courses. Develop requirements by following the approved design, coding guidelines, and coding standards. Familiarize yourself with Cytel’s values and competencies required to succeed in your job and incorporate in your work. Qualifications Bachelor’s or Master’s degree in Computer Science & Engineering (CSE) or equivalent STEM degree are preferred; however, candidates from other disciplines with relevant skills and competencies may also be considered. Experience And Skills 0-2 years of experience in developing desktop apps or web apps Knowledge of programming in Python preferred Knowledge of web development using C#.net, HTML, CSS, JavaScript, React preferred Good to have: Basic knowledge of databases (e.g., PostgreSQL) Quick learner with strong numerical & verbal aptitude, logical reasoning, and analytical ability Self-driven with the ability to think creatively and solve complex problems. Strong verbal and written English communication skills Collaborative mindset Experience working in Agile teams and knowledge of frameworks like Scrum About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Show more Show less

Job Description As a Software Engineer, the person will contribute to the development of product software. Depending upon the project need, the person may develop front- or back-ends of rich, interactive cloud-native apps, interactive dashboards and visualizations for data-intensive scientific apps, rich desktop apps. Responsibilities Study and understand the software requirements and participate actively in requirements discussions. Develop and execute automated unit tests for your code, ensuring adequate code coverage. Address code review comments in a timely manner. Troubleshoot, debug and fix defects in the application. Document code as per the standard process, and support tech leads in your code’s integration with other parts of the application. Identify and list opportunities for code refactoring and share those with your tech leads. Estimate and plan your own work and deliver as per the plan. Work within an Agile Scrum team by collaborating with tech leads, Subject Matter Experts, and other team members. Master relevant software development practices, tools, and technologies. Comply with relevant company policies. Keep knowledge up to date by undergoing appropriate trainings and courses. Develop requirements by following the approved design, coding guidelines, and coding standards. Familiarize yourself with Cytel’s values and competencies required to succeed in your job and incorporate in your work. Qualifications Bachelor’s or Master’s degree in Computer Science & Engineering (CSE) or equivalent STEM degree are preferred; however, candidates from other disciplines with relevant skills and competencies may also be considered. Experience And Skills 0-2 years of experience in developing desktop apps or web apps Knowledge of programming in Python preferred Knowledge of web development using C#.net, HTML, CSS, JavaScript, React preferred Good to have: Basic knowledge of databases (e.g., PostgreSQL) Quick learner with strong numerical & verbal aptitude, logical reasoning, and analytical ability Self-driven with the ability to think creatively and solve complex problems. Strong verbal and written English communication skills Collaborative mindset Experience working in Agile teams and knowledge of frameworks like Scrum About Us Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Come be a part of a team where talent, experience and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative and rigorous biostatistics, statistical programming and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture. Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit! Job Info Job Identification 775 Job Category Software Engineering Posting Date 05/30/2025, 06:47 AM Locations 5th Floor, Lohia-Jain IT Park, Pune, Maharashtra, 411038, IN Apply Before 06/01/2025, 12:00 PM Job Schedule Full time Show more Show less

Job Description Position: Medical Coder - Work from Home Ct: HR KAMATCHI - 8925264660 Job Description:Medical Coding is the process of conversion of text information related to healthcare services into numeric Diagnosis (Medical Problems) and Procedure (Treatments) Codes using ICD-10 CM and CPT code books. Requirement knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills No of vacancy: 500 Eligibility Nursing GNM/DGNM Life science graduates Pharmacy Physician assistant Bio medical Engineers Bio chemistry Bio technology Bio informatics Micro biology Zoology and Advanced zoology Biology Botany Plant biotechnology Genetics Food and Nutrition Paramedical Physiotherapy M.Sc. Clinical Nutrition M.Sc. Human Genetics M.Sc. Medical Laboratory Technology M.Sc. Medical Sociology M.Sc. Epidemiology M.Sc. Molecular Virology M.Sc. Biostatistics M.Sc. Blood Banking Technology M.Sc. Rgnerative Medicine M.Optom. M.Sc. Genetic Counseling M.Sc. Radiolog Imaging Technology M.Sc. Medical Biochemistry M.Sc, Medical Microbiology M.Sc. Clinical Care Technology M.Sc. Clinical Care Technology M.Sc. Medical Physics B.Sc. - Accident Emergency Care Technology B.Sc. - Audiology speech Language Pathology B.Sc. - Cardiac Technology B.Sc. - Cardio Pulmonary Perfusion Care Technology B.Sc. - Critical Care Technology B.Sc. - Dialysis Technology B.Sc. - Neuro Electrophysiology B.Sc. - M.L.T. B.Sc. - Medical Sociology B.Sc. - Nuclear Medicine Technology B.Sc. - Operation Theatre Anaesthesia Technology Bachelor of Science in Optometry B.Sc. - Physician Assistant B.Sc. - Radiology Imaging Technology B.Sc. - Radiotherapy Technology B.Sc. - Medical Record Science B.Sc. - Respiratory Therapy B.Sc. - Fitness and Lifestyle Modifications Accident Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre Anaesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Salary 15K to 17K (fresher) To 50K (experienced) Pm (Incentives Benefits as per Corporate Standards) 4K fixed hike after six months Other Benefit Pick Up Drop Facility Food Facility Day Shift Weekend Off Reach Us HR KAMATCHI 8925264660 Required Candidate profile Nursing Freshers Pharmacy Freshers Physiotherapy Dentist Life sciences Biotechnology Microbiology Biomedical Biochemistry Bioinformatics Botany Zoology GNM DGNM Physician assistant Anesthesia technician Perfusion Technology Medical coder Freshers Medical coding Freshers jobs in chennai Medical coding openings in chennai Wanted Medical coder Freshers jobs Medical coding Medical coder Medical coding Freshers Jobs in chennai Jobs for Passed outs Freshers jobs in chennai Jobs for freshers Nursing jobs for freshers Pharma jobs for Freshers Biotechology Jobs Microbiology jobs Biomedical jobs Bioinformatics jobs Bsc/Msc Jobs Biochemistry jobs Life science jobs in chennai Paramedical jobs in chennai Jobs in Tamilnadu Jobs in Pharmacy Jobs in Hospital Perks and Benefits Incentives Benefits as per Corporate Standards This job is provided by Shine.com Show more Show less

Job Description Step into the role of Executive Director, Head of Business Intelligence & Offshore Analytics, and lead our offshore team in shaping the future of our Business Banking business. You'll be responsible for all aspects of our Business Intelligence and production reporting, managing analytics and data resources, and implementing BI/reporting, analytics, AI/ML, and data strategies. With your strong analytical skills and expertise in financial services, you'll tackle complex problems, develop innovative solutions, and make a significant impact on our business. As an Executive Director, Head of Business Intelligence & Offshore Analytics within our Business Banking team, you will be responsible for leading customer-centric development, inspiring innovative solutions, and shaping the future with your strategic vision. Your role will involve leading our offshore team and managing all aspects of our Business Intelligence and production reporting for Business Banking stakeholders. This position requires a blend of consultation and leadership in the development and implementation of BI/reporting, analytics, AI/ML, and data strategies throughout our Business Banking business. You will be tasked with solving complex problems that lack defined solutions, requiring your team to assess and understand the situation, then develop BI/reporting, analytics, AI/ML, and data solutions to proactively address it. Job Responsibilities Develop and support innovative BI/reporting, analytics, data strategies and AI/ML for Business Banking that will leverage new and existing data sources related to customers, products, accounts, transactions, channels. Manage all Business Intelligence and reoccurring reporting that supports Controls, Products, Marketing, Sales and CAO stakeholders Interface directly with senior executives in Product, Sales, Marketing, Controls, Finance, Strategy, and Data & Analytics teams across the organization Solve key business problems by leading the practical application of BI/data visualization, data sciences/analytics, and data design efforts Mentor, develop, and lead our Offshore team of talented advanced analytics, BI, and data professionals Understand client’s business challenges to efficiently structure practical solutions that create favorable business impact Develop AI/ML/LLM solutions to support use cases to support our BB clients and D&A needs Innovate with the customer and business impact in mind Partner with with multiple business partners, clients, and senior executives skillfully and communicate with them at their level of analytical/technical understanding Required Qualifications, Capabilities, And Skills BS Degree in a quantitative field and 10+ years of producing and overseeing advanced BI and analytics work to include people management and development Global and US Financial Services experience to effective manage Offshore resources to support and own end-to-end functions, and enhance team integration with key stakeholders Experienced in the practical use of customer/account data, channel usage, and client profitability for analytics, segmentation, management insights, loan and product pricing, and sales management to drive market share growth and profitability improvements Seasoned Analytics professional with broad knowledge of quantitative and analytical concepts, methods, tools, and technologies Proficiency in data analysis languages (i.e. Python, SAS, Java, R, JavaScript, C++, Scala) relational databases/tools (i.e. SQL, Teradata, Snowflake, Data Bricks), and BI/Reporting tools (i.e. Tableau, Alteryx, etc) Experience with Public and Private Cloud platforms such as AWS, Azure, etc. Robust technical experience in data extraction, transformation, and load (ETL) processing Hands-on experience in delivering BI/reporting, analytics and insights to multiple levels of management supporting Product, Strategy, Finance, and Sales Demonstrates well-rounded skills in a variety of areas including: time series analysis, learning algorithms, dimensionality reduction, experimental design, A/B and multivariate testing, and matched pairs analytics Skilled at creating impactful presentations in a consultative and influential manner at the executive level Strong controls mindset and experience Preferred Qualifications, Capabilities, And Skills MBA, Master's, or PhD in a quantitative field preferred: Statistics, Applied Mathematics, Computing and Information Theory, Econometrics, Biostatistics, Operations Research, or Industrial / Electrical Engineering Financial Service industry experience desired, but we are open to evaluating candidates with strong analytics backgrounds from other industries Strong knowledge of Consumer/Wealth/Investment/Small Business products and services, including deposits, lending, cash management, investments, credit cards and merchant services Strong Management experience, including teams that are located offshore ABOUT US JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world’s most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation. About The Team Our Consumer & Community Banking division serves our Chase customers through a range of financial services, including personal banking, credit cards, mortgages, auto financing, investment advice, small business loans and payment processing. We’re proud to lead the U.S. in credit card sales and deposit growth and have the most-used digital solutions – all while ranking first in customer satisfaction. Show more Show less