Responsibilities Main point of client contact and study team for all DM related matters Execute all DM start-up activities, including the development and maintenance of eCRFs Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock Set and create the data base and support the development of the study eCRF and then validate them, assessing the correct functionality of the eCRF developed, in compliance with the applicable quality validation standards Coordinate and execute the coding activities (by using the known dictionaries, e.g. MeDRA, WHO etc), drug safety reconciliation and data review Qualifications Min 5 years relevant data management experience in the CRO/pharmaceutical industry required EDC experience required Proven ability to use statistical software - SAS Demonstrates knowledge of GCPs and protocol Strong time management and prioritisation skills to meet deadlines Strong project management & communication skills (verbal/written) Experience in pharmacology and drugs life cycle Knowledge of ICH-GCP Strong analytic and quantitative background Excellent Microsoft Office Skills
Responsibilities Main point of client contact and study team for all DM related matters Execute all DM start-up activities, including the development and maintenance of eCRFs Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock Set and create the data base and support the development of the study eCRF and then validate them, assessing the correct functionality of the eCRF developed, in compliance with the applicable quality validation standards Coordinate and execute the coding activities (by using the known dictionaries, e.g. MeDRA, WHO etc), drug safety reconciliation and data review Qualifications Min 5 years relevant data management experience in the CRO/pharmaceutical industry required EDC experience required Proven ability to use statistical software - SAS Demonstrates knowledge of GCPs and protocol Strong time management and prioritisation skills to meet deadlines Strong project management & communication skills (verbal/written) Experience in pharmacology and drugs life cycle Knowledge of ICH-GCP Strong analytic and quantitative background Excellent Microsoft Office Skills Show more Show less
Key Responsiblities Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Strong proficiency implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) Develop and review SAS programs for data analysis, tables, figures, and listings, and ensure accuracy and consistency of data output Qualifications: Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, computer science, bioinformatics, Minimum 4 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry. Strong expertise in SAS programming, and proficiency in other statistical software such as R and Python Onsite in Noida , Uttar Pradesh
As a qualified candidate for the position, you will be responsible for utilizing your strong SAS data manipulation, analysis, and reporting skills, along with a robust output programming experience. Your expertise in implementing the latest CDISC SDTM/ADaM standards will be essential for this role. Additionally, your familiarity with the drug development life cycle and experience in manipulating, analyzing, and reporting clinical trials data will be crucial. Your primary responsibilities will include the development and execution of statistical analysis and reporting deliverables, such as safety and efficacy analysis datasets, tables, listings, and figures. You will also be expected to develop and review SAS programs for data analysis, tables, figures, and listings to ensure the accuracy and consistency of data output. To be considered for this role, you must hold a Bachelors or Masters degree in a data science field, such as statistics, mathematics, computer science, or bioinformatics. A minimum of 4 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry is required. You should also possess strong expertise in SAS programming, as well as proficiency in other statistical software such as R and Python. This position is based onsite in Noida, Uttar Pradesh.,
Key Responsiblities Strong SAS data manipulation, analysis and reporting skills- with strong outputprogramming experience Strong proficiency implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) Develop and review SAS programs for data analysis, tables, figures, and listings, and ensure accuracy and consistency of data output Qualifications: Bachelors or Masters degree in a data science field, e.g., statistics, mathematics, computer science, bioinformatics, Minimum 4 years of SAS programming experience supporting clinical trials in thePharmaceutical & Biotech industry. Strong expertise in SAS programming, and proficiency in other statistical software such as R and Python Onsite in Noida , Uttar Pradesh Show more Show less
Medtek is growing data science driven company to support faster drug development and healthcare solutions. ESSENTIAL DUTIES AND RESPONSIBILITIES OF PRINCIPAL STATISTICAL PROGRAMMER- Independently Lead statistical programming activities for Phase 1/2/3 studies Create SDTM Spec and program and validate SDTM datasets Create ADaM Spec and program and validate ADaM datasets Create Safety and Efficacy Tables, Listing and Graphs Review Pinnacle 21 reports. Debug macros and create study specific macros if needed. Deliver good quality regulatory outputs for FDA/EMA and other submissions Able to multitask and work in a matrix environment Able to program and deliver in independently with minimum guidance Able to work in multitasking environment and lead studies Pay attention to details and provide timely updates. Provide technical guidance to other statistical programmers and ensure training and development of team members. Learn new skills as needed Good Communication skills SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • Bachelors or Master in Statistics, computer science or analytical field with 6+ year experience in CRO/Pharma or Biotech industry • Experience in Oncology domain a plus • 7 + year of Statistical programming experience • CDISC (SDTM , ADaM) experience a must • Good oral and written communication skills Job Type: Full-time Pay: 25-30 Lacs P.A. Schedule: • 8 hour shift
Requirement : This role is responsible for overall development, configuration and maintenance of Argus Safety Experience in Argus Console and Argus Administration activities Experience on configuration of reporting destinations, reporting rules and configuration of Advance Conditions and Advance Condition Sets based on project requirements Experience in Code Lists, Business Configuration, Access Management and System Configuration Experience in Configuration and providing support to periodic reports - DSUR,PADER,PBRER,CIOMS II Line Listings and X monthly SUSAR Line listings and other adhoc reports based on client needs. Experience in periodic reports in Argus Application ,PV Reports and Oracle Analytics tools Develop, Test & Execute advanced SQL, Ad-hoc queries on ARGUS database. Prepare Analysis of Similar Events (AOSE) for expedited reports. Assess SAE reports for completeness, consistency, serious criteria, event expectedness, and reportability. Qualification: Min 7 years of experience in Argus report generation for PV group. Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, computer science, bioinformatics. Healthcare/Lifesciences Industry experience is a must.
Role Overview: You will be responsible for the overall development, configuration, and maintenance of Argus Safety. Your key responsibilities will include experience in Argus Console and Argus Administration activities, configuration of reporting destinations, reporting rules, and configuration of Advance Conditions and Advance Condition Sets based on project requirements. Additionally, you will be working on Code Lists, Business Configuration, Access Management, and System Configuration. You will also be involved in providing support for periodic reports such as DSUR, PADER, PBRER, CIOMS II Line Listings, X monthly SUSAR Line listings, and other adhoc reports based on client needs. Your role will involve working on periodic reports in Argus Application, PV Reports, and Oracle Analytics tools. You will also need to develop, test, and execute advanced SQL, Ad-hoc queries on ARGUS database. Furthermore, you will be responsible for preparing Analysis of Similar Events (AOSE) for expedited reports and assessing SAE reports for completeness, consistency, serious criteria, event expectedness, and reportability. Qualification Required: - Minimum 7 years of experience in Argus report generation for PV group. - Bachelors or Masters degree in a data science field, e.g., statistics, mathematics, computer science, bioinformatics. - Healthcare/Lifesciences Industry experience is a must.,
Role Overview: You will be responsible for the overall development, configuration, and maintenance of Argus Safety. Your main tasks will include working with Argus Console and handling Argus Administration activities. Additionally, you will configure reporting destinations, reporting rules, and Advance Conditions and Advance Condition Sets based on project requirements. Your role will involve managing Code Lists, Business Configuration, Access Management, and System Configuration. You will also provide support for periodic reports such as DSUR, PADER, PBRER, CIOMS II Line Listings, X monthly SUSAR Line listings, and other adhoc reports based on client needs. Moreover, you will work on periodic reports in Argus Application, PV Reports, and Oracle Analytics tools. Your responsibilities will also include developing, testing, and executing advanced SQL, as well as preparing Analysis of Similar Events (AOSE) for expedited reports. Lastly, you will assess SAE reports for completeness, consistency, serious criteria, event expectedness, and reportability. Key Responsibilities: - Develop, configure, and maintain Argus Safety - Work with Argus Console and handle Argus Administration activities - Configure reporting destinations, reporting rules, and Advance Conditions - Manage Code Lists, Business Configuration, Access Management, and System Configuration - Provide support for periodic reports (DSUR, PADER, PBRER, CIOMS II Line Listings, etc.) - Develop, test, and execute advanced SQL queries on ARGUS database - Prepare Analysis of Similar Events (AOSE) for expedited reports - Assess SAE reports for completeness, consistency, serious criteria, and reportability Qualifications Required: - Minimum 7 years of experience in Argus report generation for PV group - Bachelors or Masters degree in a data science field (e.g., statistics, mathematics, computer science, bioinformatics) - Healthcare/Lifesciences Industry experience is a must.,
Key Responsiblities Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Strong proficiency implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) Develop and review SAS programs for data analysis, tables, figures, and listings, and ensure accuracy and consistency of data output Qualifications: Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, computer science, bioinformatics, Minimum 4 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry. Strong expertise in SAS programming, and proficiency in other statistical software such as R and Python Onsite in Noida , Uttar Pradesh
As an experienced professional in the field of Argus Safety, your role will involve the overall development, configuration, and maintenance of Argus Safety. You will be responsible for various activities including configuration of reporting destinations, reporting rules, and Advance Conditions tailored to project requirements. Your expertise in areas such as Argus Console, Argus Administration, Code Lists, Business Configuration, Access Management, and System Configuration will be essential for success in this role. Additionally, you will be involved in supporting periodic reports such as DSUR, PADER, PBRER, CIOMS II Line Listings, SUSAR Line listings, and other adhoc reports based on client needs using Argus Application, PV Reports, and Oracle Analytics tools. Key Responsibilities: - Experience in Argus Console and Argus Administration activities - Configuration of reporting destinations, reporting rules, and Advance Conditions - Expertise in Code Lists, Business Configuration, Access Management, and System Configuration - Support periodic reports including DSUR, PADER, PBRER, CIOMS II Line Listings, SUSAR Line listings, and adhoc reports - Develop, test, and execute advanced SQL, Ad-hoc queries on ARGUS database - Prepare Analysis of Similar Events (AOSE) for expedited reports - Assess SAE reports for completeness, consistency, serious criteria, event expectedness, and reportability Qualifications Required: - Minimum 7 years of experience in Argus report generation for PV group - Bachelors or Masters degree in a data science field (e.g., statistics, mathematics, computer science, bioinformatics) - Healthcare/Lifesciences Industry experience is a must In addition to the above qualifications and responsibilities, please note that this position requires strong attention to detail, analytical skills, and the ability to work effectively in a fast-paced environment within the Healthcare/Lifesciences industry.,
Company Description MEDTEK AI is a data science-driven company that accelerates drug development and healthcare solutions. Our team comprises senior statisticians, data scientists, statistical modeling experts, programming experts, data visualization professionals, cloud data engineers, data lake strategists, regulatory submission consultants, and drug safety consultants. We provide support to pharmaceutical and biotechnology companies across America, Japan, and the EU. Role Description This is a full-time, on-site role for a Technical Recruiter located in Noida. The Technical Recruiter will be responsible for managing the full life cycle recruiting process, including sourcing, interviewing, and hiring candidates for technical positions. Day-to-day tasks include job posting, candidate screening, scheduling interviews, conducting initial interviews, coordinating with hiring managers, and extending job offers. The recruiter will also work on building a network of potential candidates and maintaining a database of qualified candidates. Qualifications Experience in Full-life Cycle Recruiting, Hiring, and Technical Recruiting Strong skills in Recruiting and Communication Ability to work collaboratively with internal teams and hiring managers Familiarity with applicant tracking systems and recruiting tools Excellent organizational and time-management skills Bachelor's degree in Human Resources, Business Administration, or related field