Bhanu Prakash Mullaguri

A competent Certified Base SAS Programmer and 2+ years of experience as an Associate SDTM Programmer, having good knowledge in BASE SAS, SAS SQL, SAS Macros

• Contribute computer programming efforts for a clinical trial drug project and to provide programming support for clinical trial data reporting and regulatory submissions implementation
• Created SDTM data sets from raw datasets
• Involved in writing SAS programs based on Statistical Analysis Plan (SAP) using SAS tools to generate statistical reports, listings, tables for analysis of clinical data
• Support the Programming and Statistics lead for project management at various protocol level
• Extensive knowledge of clinical trials (I, II, III, IV phases) in various therapeutic areas such as Neuroscience, GLP-1 Diabetes, OSCD & Outcomes, Obesity & NASH, Rare Diseases (Haemophilia)
• Good knowledge of SAS procedures (PROC Means, PROC Freq, PROC Transpose, PROC Sort, PROC Format, PROC Report, PROC Contents, PROC Import and PROC Export
• Create and maintain aCRF (annotated Case Report Form) along with QC of aCRF
• Generate SDTM datasets and perform QC
• Create Define.xml Create and maintain SDRG (Study Data Reviewer`s Guide) Run Pinnacle21 (P21) checks and resolve issues by coordinating with Trial Data Management
• Create Define.xml
• Create and maintain SDRG (Study Data Reviewer`s Guide)
• Run Pinnacle21 (P21) checks and resolve issues by coordinating with Trial Data Management, Clinical Data Programmer and Biostats Community
• Good Knowledge of SDTM IG
• Good Knowledge of ICH and Regulatory guidelines
• Working knowledge of clinical data and relevant data standards
• Review and provide inputs to Data collection requirements in relation but not limited to protocol, flowchart, SDTM domains, etc.
• Prepare metadata specification and aCRF, submit the request to control of standards group to either deviate from an existing standard or use a trial-specific element in alignment with Lead SDTM Programmer
• Ensure initial Meta data Management (MMA) setup is done as per the trial requirement
• Review SDTM test data (as required)
• Review and provide input to external data specifications including but not limited to lab, eDiary
• Review and provide inputs to project plans review and provide inputs to blinding plan and blinding implementation document
• Review of (e)CRFs. Special attention should be given to non-standard modules regarding the impact on SDTM
• Request codes/topic codes as needed
• Perform custom programming on trial-specific needs if required and validate according to relevant SOP
• Create and maintain aCRF (annotated Case Report Form) along with QC of aCRF
• Generate SDTM datasets and perform QC
• Ensure peer review of the mappings when generated out of Clinical Data Warehouse (CDW Operations) and validate custom programs used in the generation of SDTM datasets according to relevant SOP
• Create Define.xml
• Create and maintain SDRG (Study Data Reviewer`s Guide)
• Run Pinnacle21 (P21) checks and resolve issues by coordinating with Trial Data Management,Clinical Data Programmer and Biostats Community
• Ensure SDTM IG is followed
• Finalize SDTM package and perform complete run in alignment with Biostats
• Perform Database setup in Clinical Data Warehouse (CDW Operations)
• Perform Mappings in the Clinical Data warehouse (CDW Operations)
• Creating ER Instances and non-ER Instances by using UNIX SCE (Whale Server)

Therapeutic areas : GLP-1 Diabetes, OSCD & Outcomes, Obesity & NASH, Rare Diseases

(Hemophilia)

• Therapeutic area: Neuroscience
• Study design:
• A Phase II, Multicenter, Randomized, Placebo-Controlled Clinical Trial Evaluate the Safety and activity when administered to patients with major depressive disorder
• Responsibilities: Develop SDTM datasets from raw datasets
• Develop SAS programs for ADaM data sets as per specifications Develop SAS programs for generating Tables, Listings as specified
• Created tables according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS
• PROC FREQ, PROC TRANSPOSE, PROC REPORT, etc., and procedures.