Goutam Roy Email & Phone Number

A believer to be growing slowly || Through seeing things outside of the box || Committed to acquire quality things in a consistent manner.

Listed skills include Sas Programming, Nonmem, Powerpoint, Microsoft Excel, and 13 others.

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  Quality System Manager And Statistical Programmer

  Shafi Consultancy Limited

  May 2019 - Present - Sylhet, Bangladesh

  As Quality System Manager my responsibility includes:▪ Developing, implementing, and maintaining integrated quality management systems for the company which includes developing the quality strategy, policies, and processes for the company.▪ Ensure the procedures and guidelines are reviewed and updated in a timely manner to meet the needs of applicable regulatory bodies.▪ To be aware of current laws, regulations, guidelines, and ensure that the staffs are up to that standard.▪… Show more As Quality System Manager my responsibility includes:▪ Developing, implementing, and maintaining integrated quality management systems for the company which includes developing the quality strategy, policies, and processes for the company.▪ Ensure the procedures and guidelines are reviewed and updated in a timely manner to meet the needs of applicable regulatory bodies.▪ To be aware of current laws, regulations, guidelines, and ensure that the staffs are up to that standard.▪ Conduct the internal audit and summarize the report to the senior management, attend the client audit.▪ Act as the primary contact for undertaking complaints and corrective/preventive action processes.As Statistical Programmer my responsibility includes:▪ Reading and understanding client’s requirements to analyze different phases of clinical trial data in different therapeutic areas such as cardiovascular disease, hematology, and so on, and Pharmacokinetic and Pharmacodynamic analysis▪ Extracting data from different sources, checking data issues, directly communicate with clients regarding data issues.▪ Writing and validating specification for CDISC standard projects.▪ Developing program to generate SDTM domain, ADaM and TLG.▪ Validating SDTM, ADaM data in Pinnacle 21 Open CDISC software and performing independent QC.▪ Writing specification to generate NONMEM, PKPD datafile, check source data, communicate with data manager regarding data issues and data cleansing.▪ Writing program to create NONMEM, PKPD datafile using SDTM as well as legacy data.▪ Developing consistent check programs to perform independent QC procedures for PKPD datafile maintaining professional programming standards.▪ Developing generic macro to reduce the repetitive tasks.▪ Developing training materials and provide training to the newly started SAS programmers. Show less