Naveen Sandi
Hyderabad
Summary
Skilled and highly committed SAS certified Programmer with 10 years of experience in Clinical Industry covering all aspects of SAS processes – data mapping, analysis, validation, reporting applied in Pharmaceutical and Biotech industries (Clinical Environment). Enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow and excel in the industry
Overview
10
10
years of professional experience
Work History
Associate Manager, Statistical Programming
Parexel International India Pvt Ltd
Hyderabad
2022.11 - Current
- Act as a Primary lead for few studies and also oversee Individual accounts for 10 - 12 studies with respect to resourcing, budget, planning and execution.
- Involved in end to end development activities like SDTM, ADaM, TLF programming and specification creation for clinical studies.
- Perform senior review of the outputs generated by the programmers as a part of the quality check.
- Ensure team is delivering first time quality deliverables to the customer and proper regulatory documentation is completed for every deliverable.
- Remedied issues and conflicts among workers using negotiation and active listening.
- Mentored team members to enhance professional development and accountability in workplace.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Developed and implemented business strategies to achieve business goals and stay competitive.
- Planned and budgeted accurately to provide business with resources needed to operate smoothly.
Principal Statistical Programmer
PAREXEL International India Pvt Ltd.
Hyderabad
2021.06 - 2022.10
- Served as primary SAS programmer and collaborate with statistician in analyzing initial data sets and generating tables, listings and figures (TLFs) for clinical trials.
- Served as Statistical Programming Lead for 4 projects and POC for 2 projects. Provided clinical programming expertise and hands on support to clinical projects across multiple therapeutics areas.
- Coordinate with Project Managers on budget review for project and complete study submission with in scoped budget with first time quality.
- Deliver global level trainings with in department and team. Taken ownership and initiatives to improve quality of project deliverables within team.
- Experienced in Team management, handling team members resourcing, operational metrics and project related issues.
- Oversee clinical SAS programming and analysis functions and support for entire clinical studies across multiple protocols for submissions such as CSR and Safety.
- Provided strong technical programming support to support programmers in project.
- Play key role in developing, debugging, and validating project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings.
- Hands on experience in implementing CDISC standards SDTM and ADAM. Developing SDTM & ADAM Specifications.
Senior Statistical Programmer
PAREXEL International India Pvt Ltd.
Hyderabad
2018.11 - 2021.05
- Worked on Phase I, II ,III, IV Clinical Trials data for various therapeutic areas.
- Performed Data analysis, generated Tables, listings according to SAP and based on mock shell.
- Worked on both CDISC and non-CDISC standard dataset as per client requirement and need. Created specifications for SDTM and ADAM dataset programming.
- Over years have worked as Statistical Programming Lead, have successfully lead study programming teams and manage projects to ensure first time quality of work and completed deliverables within timeline.
- Performed weekly meetings with study team to understand work progress .
- Participated in Weekly Client Meetings and weekly priorities meetings to discuss requirements and gather client comments on current study and set programming priorities.
- Developed validated and documented programs to create TLG's Tables, Listings and Graphs as per
- Statistical Analysis Plan SAP using SAS reporting procedures like PROC REPORT, PROC SORT, PROC TRANSPOSE and analysis procedures like PROC MEANS and PROC FREQ.
Statistical Programmer II
PAREXEL International India Pvt Ltd.
Hyderabad
2016.05 - 2018.10
- Programmed CDISC SDTM datasets, crf Annotation, creating SDTM specification, e-submission package.
- Worked on Sponsor specific standards to create DTMS and Standard Mapping programs.
- Reporting data issues to Data management team after review of Pinnacle 21.
- Programmed safety tables, listings and reports. Performed QC of tables and listings by output level QC.
- Suggested and lead process improvement idea to streamline offline edit checks listings.
Statistical Programmer I
PAREXEL International India Pvt Ltd.
Hyderabad
2015.03 - 2016.04
- Assisted and provided support on new and ongoing studies interacting with Data management team.
- Programmed for production/ validation of sponsor-specific mapping datasets (analogous to CDISC SDTM datasets)
- Programmed offline listings, PD listings and Clinician listings etc.
- Worked on handling lab data to populate lab ranges correctly.
Clinical Data Programmer
ICON Plc
Chennai
2013.04 - 2015.02
- Extracted datasets from database using SAS/ACCESS, LIBNAME Statement and other Import methods.
- Verified accuracy and integrity of Clinical data by performing validation checks written in SAS and
- Data cleaning by developing SAS Edit checks.
- Worked closely with Data Management in providing required reports that include SAE, LAB Reconciliation reports.
- Involved in developing SDTM programs and creating SDTM datasets as per Data transfer mapping specification.
- Involved in developing SDTM data transfer mapping specification according to CDISC standards. Review of Pinnacle 21.
Education
Technology - SAS
Certified SAS Professional
EPOCH Research Institute India Pvt Ltd.Bachelor of Pharmacy - Pharmaceutical Sciences
SSJ College of Pharmacy
HyderabadSkills
Statistical reportingundefined
Accomplishments
- Achieved Quarterly India country head recognition award 2023 for completing project submission for FDA with accuracy and efficiency.
- Delivered high complex Phase III clinical trial FDA, PMDA submission under very short timelines with first time quality.
- Collaborated with global team members in the development of Statistical Programming SOP's to streamline the project submission documentation.
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Timeline
Associate Manager, Statistical Programming
Parexel International India Pvt Ltd
2022.11 - Current
Principal Statistical Programmer
PAREXEL International India Pvt Ltd.
2021.06 - 2022.10
Senior Statistical Programmer
PAREXEL International India Pvt Ltd.
2018.11 - 2021.05
Statistical Programmer II
PAREXEL International India Pvt Ltd.
2016.05 - 2018.10
Statistical Programmer I
PAREXEL International India Pvt Ltd.
2015.03 - 2016.04
Clinical Data Programmer
ICON Plc
2013.04 - 2015.02
Technology - SAS
Certified SAS Professional
Bachelor of Pharmacy - Pharmaceutical Sciences
SSJ College of Pharmacy
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