MEDTEK AI

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