rajesh lingala

Clinical sas programmer

• Working as a role of Senior Executive clinical SAS in Hetero Labs Ltd, Hyderabad from

                                                                                                    (15-06-2022 to till continue.).

Roles and Responsibilities;

• Working with SAS on analysis, developing, testing and implementation of various projects related therapeutic areas like Cardiovascular, Diabetic, CNS, Respiratory system.
• knowledge on the drug development process with analyzing and reporting Phase I, II, III of clinical trial data. 
• Having knowledge in SAS/BASE, SAS/MACROS, SAS/SQL and SAS/STAT, SAS/GRAPH, SAS/ODS (RTF, PDF, HTML) procedures.
• Experience in converting raw-data into SAS datasets, modifying datasets and have knowledge on report generation using Base SAS procedures.
• Comprehensive prepared reports using SAS report generating procedures like PROC MEANS, PROC REPORT, PROC FREQ, PROC UNIVARIATE, PROC TRANSPOSE, PROC SORT and PROC COMPARE. 
• Knowledge in SAS FUNCTIONS, STATEMENTS and SAS FORMATS / INFORMATS.
• Accessing excel files using PROC IMPORT procedure.
• Thoroughly understand trial related documents such as Protocol, eCRF and CRF-Annotation.
• Mapping the raw data to target SDTM domains like DM, SE, SV, CM, EX, AE, PE, DS, MH, VS, LB, CO and some others and Supplementary datasets as per CDISC – SDTM IG v3.2 and 3.3.
• Validating the data using PROC COMPARE.
• Worked on creation of ADaM datasets like ADSL, ADAE, ADCM, ADVS, ADLB as per AdaM IG v1.2.
• Generation of summary of safety and Efficacy Tables and Listing and figures.
• Knowledge on Trial Design Models.
• Experienced in the creation of transport (.XPT) files using proc copy.
• Produced quality customized reports by using Proc Report for the submission as per the FDA regulations, GCP, 21 CFR part 11, ICH and company standards and other regulatory submissions to NDA.
• Cross-validate SAS programs for derived Datasets, Tables and Listings authored by other SAS programmers as a part of quality assurance using PROC COMPARE.
• Created study level Macro’s also used existing Macros, developed SAS Programs for Data cleaning, Data validation, Data analysis and Report generation.
• Knowledge on Ideal terminology of MedDRA and WHO drug.
• Knowledge on Pinnacle 21 and Define .XML procedures.
• Adequate knowledge in MS office.

• Worked as a role of Executive clinical SAS in Caplin sterile Ltd, Chennai from 1 year 5 months of experience                                                                 (15-02-2021 to 14-06-2022)

Roles and Responsibilities;

Supported in clinical trial project and created SDTM datasets like Demographics (DM), adverse events (AE), Exposure (EX), Concomitant medications (CM), vital signs (VS) and Disposition (DS). Preparing SDTM mapping specifications and programming for generating CDISC SDTM based on study documents such as a- CRF and protocol.

Developed programming codes by using SAS BASE, Macros, PROC SQL procedures.

• Gap in employment: 2 years (from Jan 2019 to Jan 2021) due to education and learning of clinical SAS and some personal family issues. 

• Worked as a role of Analytical Research & Development Executive in Global pharma tech, Hosur from 10 months of experience                             (20-02-2018 to 03-12-2018)

Basic knowledge on QMS and Analytical Documents Review, OOS, Deviations in QC & AR&D.

Handling of Caliber LIMS software for all activities in lab.

Handling of Change controls, Incidents, CAPA management.

Review of Validation Protocols, Reports, SOPS, Training Related documents.

Instrument/Equipment’s Qualifications, Daily monitoring of GLP practice in Lab.

• Worked as a role of AR&D Executive in Bluefish pharmaceuticals Pvt Ltd in Bangalore had 2 years of experience                                                          (29-03-2016 to 07-02-2018).

Roles and Responsibilities;

Handling of Caliber LIMS software for all activities in lab.

Review of Validation Protocols, Reports, SOPS, Training Related documents.

Handling of Dissolution apparatus and UV, HPLC.

• Worked as a role of Hospital Pharmacist in Indus hospitals in Vizag in the year of 2012 to 2013.

Roles and Responsibilities;

Inpatient medicine issuance based on doctor’s prescription.

• Clinical SAS Programmer Relevant experience: 2 years 6 months
• Total experience: 6 years 5 months
• Notice Period: 3 months.