529 Biostatistics Jobs - Page 18

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha Show more Show less

Central Monitor II - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5687 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 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. Apply Now Show more Show less

Principal Central Monitor - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5683 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 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. Apply Now Show more Show less

Senior Central Monitor - Location: Bangalore Karnataka India Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5684 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 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. Apply Now Show more Show less

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha Show more Show less

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha Show more Show less

Job Description A minimum of 10 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) Independently interact with client and handle/address any queries from client Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents Good knowledge of statistical programming languages (including SAS) and R will be added advantage Adherence to SOPs and GPP Ensure teams compliance to organizational policies and procedures Quality and adherence to timelines. Skills Required RoleExpert Biostatistician Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills BIOSTATISTICIAN CLINICAL TRAILS Other Information Job CodeGO/JC/21471/2025 Recruiter NameSangeetha Show more Show less

Job Description Position: Medical Coder Ct: HR HR Shanmugapriya - 8072891550 Medical Coding is the process of converting patient health information into alpha numeric codes. Coders take medial reports from doctors, which may include a patients condition, the doctors diagnosis, a prescription, and whatever procedures the doctor or healthcare provider performed on the patient, and turn that into a set of codes, which make up a crucial part of the medical claim. Eligibility All (UG/PG) Life Science Paramedical Graduates BDS BPT BHMS BAMS Siddha,Unani,Naturopathy {Dip Bsc Msc} Nursing/GNM {B.E M.E} Biomedical Engineering {B.tech,M.tech}Biotechnology Biochemistry Bioinformatics Microbiology Zoology and Advanced zoology Biology Botany Medical Lab Tech Plant biotechnology Pharmacy(B.Pharm M.pharm) Paramedical Physiotherapy Physician assistant Critical Care Technology Medical Biochemistry Medical Record Science Operation Theatre Anaesthesia Technology {Bsc Msc Dip} Clinical Nutrition Human Genetics Medical Laboratory Technology Medical Sociology Epidemiology Molecular Virology Biostatistics Blood Banking Technology Regenerative Medicine Optom. Genetic Counseling Radiology Imaging Technology Medical Biochemistry Medical Microbiology Clinical Care Technology Clinical Care Technology Medical Physics {Bsc Msc Dip} Accident Emergency Care Technology Audiology speech Language Pathology Cardiac Technology Cardio Pulmonary Perfusion Care Technology Critical Care Technology Dialysis Technology Neuro Electrophysiology Medical Sociology Nuclear Medicine Technology Operation Theatre Anaesthesia Technology Optometry Physician Assistant Radiology Imaging Technology Radiotherapy Technology Medical Record Science Respiratory Therapy Fitness and Lifestyle Modifications Accident Emergency Care Technology Critical Care Technology Nursing Aide Operation Theatre Anesthesia Technology Ophthalmic Nursing Assistant Medical Record Science Optometry Technology Radiology Imaging Technology Medical Lab Technology Cardiac Non Invasive Technology Dialysis Technology Dentist Requirement Knowledge in Anatomy and Physiology Good communication and interpersonal skills Basic Computer Skills Benefits System based job Weekly 5 days duty Day shift with Sat and Sun off Food and Cab provided by company Incentives based on performance Starting salary 12k to 25k with increment in 6 months for experienced. Abroad opportunities available Bonus for referring friends Medical expenses covered by company Provident Fund will be provided Gratuity after 5 yrs of work experience. Job Location: Chennai, Coimbatore, Vellore, Trichy, Cuddalore, Pondi Salem, Erode, Namakkal, Thanjavur, Nagercoil, Theni,Dindokal Thiruvannamalai, Villupuram, Karur, Tirunelveli,Kanniyakumari Tirupati, Kerala, AP,Tamilnadu,Telangana Ct: HR HR Shanmugapriya - 8072891550 This job is provided by Shine.com 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 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. 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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. 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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