As a Senior Statistical Programmer on the team, I have more than 9 plus years of clinical research experience in clinical trials and health insurance
Aktualisiert am 05.06.2024
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 01.07.2024
Verfügbar zu: 100%
davon vor Ort: 100%
CDSIC
SDTM
ADAM
TLF
English
Germany
Telugu
Hindi

Einsatzorte

Einsatzorte

Deutschland
nicht möglich

Projekte

Projekte

2 years 4 months
2022-02 - now

Startdard Macro development

Prinipal Statistical Programmer (FSP model to AZ Pharma)
Prinipal Statistical Programmer (FSP model to AZ Pharma)
  • Startdard Macro development for ADAM, TLFs for all Oncology and Dermatology Projects Phase II to III
  • Specfication creation for all efficacy ADaMs ex :- ADTTE ADEFF, ADRS, ADBOR etc
  • Subgroup analysis for publications on ISS studies.
  • Programming procedures provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions develop, enhance, evaluate, and validate standardized macros and utility programs
  • Creation and Validation of TLFs Programming and creation of SDRG, ADRG documentation
TFS CRO
Berlin
1 year 7 months
2020-07 - 2022-01

Essential functions include creating systems

Senior Statistical Programmer
Senior Statistical Programmer
  • leads the programming activities for a trial, early phase project, indication, or publication activities. Develops and supports statistical
  • Essential functions include creating systems that assist the Statistical Programming staff and Biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications.
  • Developing systems to support electronic regulatory submissions providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff and biostatisticians.
  • Programming procedures provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions develop, enhance, evaluate, and validate standardized macros and utility programs
PRA Inc.
Berlin
1 year 7 months
2018-12 - 2020-06

Estimate programming scope of work

Senior Statistical Programmer
Senior Statistical Programmer
  • Developed analysis Datasets and tables and listing outputs as per the client specific specifications and the mock shells
  • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables
  • Worked on analysis data sets (ADAM) to reflect the specifications, ADAM implementation guide and the Statistical Analysis Plan (SAP)
  • Used SAS/Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, and tables
Cytel Inc.
Berlin
2 years 9 months
2015-07 - 2018-03

Directly communicate with internal and client statisticians

Senior Statistical Programmer
Senior Statistical Programmer
  • Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
  • Directly communicate with internal and client statisticians to ensure appropriate understanding of requirements and project timelines.
  • Used PROC REPORT and SAS/ODS feature to create the tables and listings
  • Involved with the Validation of SDTM datasets, ADAM datasets, tables and listings
  • Extensive experience in creating LABORATORY tables (Summary, Shift of Lab values, Shift Categorization)
  • Created standard macros and applications to improve the efficiency of the department
Chiltern International, Pvt. Ltd.
Hyderabad, Telangana / India
1 year 7 months
2014-01 - 2015-07

Vast experience in different PK/PD tables

Bio-Statistical Programmer - II
Bio-Statistical Programmer - II
  • Mainly handle the 16 phase-1 studies from CRF annotation to SDTM, ADaM and TLFs submissions
  • Worked on Different efficacy end points on Phase-1 studies , Pharmacokinetic (PK), Pharmacodynamic (PD) analysis models
  • Good experiences in PP/PC,SDTM and ADPC, ADPP datasets creations and validations
  • Experiences in PROC MIXED model to find different efficacy variables like 95%C I , Estimates, Ratios, P-Values etc
  • Vast experience in different PK/PD tables and Graphs like, Means +SD , Spaghetti plots, Box plots, Linear and scatter plots etc
  • Worked on pilot project using R software to find the mixed effect models in Phase 1 studies
  • Mainly on Fixed model and patients random effects using lme (linear mixed effect), lm (linear model) functions in R software
Parexel International.
Hyderabad, Telangana / India

Aus- und Weiterbildung

Aus- und Weiterbildung

Bachelor of Pharmacy

Osmania University, Jangaon, Warangal / India

70%/ Pharmacy


CERTIFICATIONS & PROFESSIONAL TRAINING:

  • SAS Certified Advanced Programmer for SAS 9.2
  • SAS Certified Base Programmer for SAS 9.2

Kompetenzen

Kompetenzen

Top-Skills

CDSIC SDTM ADAM TLF

Produkte / Standards / Erfahrungen / Methoden

SUMMARY:

As a Senior Statistical Programmer on the team, I have more than 9 plus years of clinical research experience in clinical trials and health insurance applications. Responsibilities include the development and validation of SDTM, ADaMs and TLFs for Phase 1 through Phase IV clinical trials for pharmaceutical, biotechnology and device products, in a wide spectrum of therapeutic areas. Prior to joining Bayer Pharma inc I have served as a Senior Statistical Programmer at PRA (ICON) ,CYTEL, CHILTERN and PAREXEL Inc. And I have strong skills include statistical programming (SAS), project management, working within a crossfunctional team environment, and a broad understanding of the domestic and international pharmaceutical development industry.


COMPUTER SKILLS:

  • SAS
  • SQL
  • UNIX
  • EG
  • SAS Studio

Einsatzorte

Einsatzorte

Deutschland
nicht möglich

Projekte

Projekte

2 years 4 months
2022-02 - now

Startdard Macro development

Prinipal Statistical Programmer (FSP model to AZ Pharma)
Prinipal Statistical Programmer (FSP model to AZ Pharma)
  • Startdard Macro development for ADAM, TLFs for all Oncology and Dermatology Projects Phase II to III
  • Specfication creation for all efficacy ADaMs ex :- ADTTE ADEFF, ADRS, ADBOR etc
  • Subgroup analysis for publications on ISS studies.
  • Programming procedures provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions develop, enhance, evaluate, and validate standardized macros and utility programs
  • Creation and Validation of TLFs Programming and creation of SDRG, ADRG documentation
TFS CRO
Berlin
1 year 7 months
2020-07 - 2022-01

Essential functions include creating systems

Senior Statistical Programmer
Senior Statistical Programmer
  • leads the programming activities for a trial, early phase project, indication, or publication activities. Develops and supports statistical
  • Essential functions include creating systems that assist the Statistical Programming staff and Biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications.
  • Developing systems to support electronic regulatory submissions providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff and biostatisticians.
  • Programming procedures provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions develop, enhance, evaluate, and validate standardized macros and utility programs
PRA Inc.
Berlin
1 year 7 months
2018-12 - 2020-06

Estimate programming scope of work

Senior Statistical Programmer
Senior Statistical Programmer
  • Developed analysis Datasets and tables and listing outputs as per the client specific specifications and the mock shells
  • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables
  • Worked on analysis data sets (ADAM) to reflect the specifications, ADAM implementation guide and the Statistical Analysis Plan (SAP)
  • Used SAS/Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, and tables
Cytel Inc.
Berlin
2 years 9 months
2015-07 - 2018-03

Directly communicate with internal and client statisticians

Senior Statistical Programmer
Senior Statistical Programmer
  • Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
  • Directly communicate with internal and client statisticians to ensure appropriate understanding of requirements and project timelines.
  • Used PROC REPORT and SAS/ODS feature to create the tables and listings
  • Involved with the Validation of SDTM datasets, ADAM datasets, tables and listings
  • Extensive experience in creating LABORATORY tables (Summary, Shift of Lab values, Shift Categorization)
  • Created standard macros and applications to improve the efficiency of the department
Chiltern International, Pvt. Ltd.
Hyderabad, Telangana / India
1 year 7 months
2014-01 - 2015-07

Vast experience in different PK/PD tables

Bio-Statistical Programmer - II
Bio-Statistical Programmer - II
  • Mainly handle the 16 phase-1 studies from CRF annotation to SDTM, ADaM and TLFs submissions
  • Worked on Different efficacy end points on Phase-1 studies , Pharmacokinetic (PK), Pharmacodynamic (PD) analysis models
  • Good experiences in PP/PC,SDTM and ADPC, ADPP datasets creations and validations
  • Experiences in PROC MIXED model to find different efficacy variables like 95%C I , Estimates, Ratios, P-Values etc
  • Vast experience in different PK/PD tables and Graphs like, Means +SD , Spaghetti plots, Box plots, Linear and scatter plots etc
  • Worked on pilot project using R software to find the mixed effect models in Phase 1 studies
  • Mainly on Fixed model and patients random effects using lme (linear mixed effect), lm (linear model) functions in R software
Parexel International.
Hyderabad, Telangana / India

Aus- und Weiterbildung

Aus- und Weiterbildung

Bachelor of Pharmacy

Osmania University, Jangaon, Warangal / India

70%/ Pharmacy


CERTIFICATIONS & PROFESSIONAL TRAINING:

  • SAS Certified Advanced Programmer for SAS 9.2
  • SAS Certified Base Programmer for SAS 9.2

Kompetenzen

Kompetenzen

Top-Skills

CDSIC SDTM ADAM TLF

Produkte / Standards / Erfahrungen / Methoden

SUMMARY:

As a Senior Statistical Programmer on the team, I have more than 9 plus years of clinical research experience in clinical trials and health insurance applications. Responsibilities include the development and validation of SDTM, ADaMs and TLFs for Phase 1 through Phase IV clinical trials for pharmaceutical, biotechnology and device products, in a wide spectrum of therapeutic areas. Prior to joining Bayer Pharma inc I have served as a Senior Statistical Programmer at PRA (ICON) ,CYTEL, CHILTERN and PAREXEL Inc. And I have strong skills include statistical programming (SAS), project management, working within a crossfunctional team environment, and a broad understanding of the domestic and international pharmaceutical development industry.


COMPUTER SKILLS:

  • SAS
  • SQL
  • UNIX
  • EG
  • SAS Studio

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