Senior Statistical Programmer |SAS|CDISC|SDTM|ADAM|UNIX

9/2018 – 6/2019

Lead three projects in programming for the client for CSR , (DSUR) Investigators brochures (IB) in Oncology Therapeutic Area and develop/validate CDISC SDTM and ADAM datasets and specifications.
Excellent knowledge of RECIST standards and CTCAE for Solid tumors.
Expert SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks and willing to learn other programming languages like R and Python.
Skilled in Conversions of SAS Datasets to various file types (including Excel, RTF, PDF, HTML,) and various file types to SAS Datasets.
Perform validation and QC of SAS outputs and advanced data manipulation or experience of managing large-scale data sets within an analytical function (e.g. SAS, SQL, etc.)
Handles Ad-hoc Request, Health authority questions and manuscripts for Biostatistics
Mentors and trains junior programmers for CDISC Standards/SAS/Macros/SQL
Strong oral and written communication skills and able to synthesis clearly complex issues
Create SAS programs, to create client specific analysis datasets, Tables, listings and figures.
Develop and validate tables, listings and figures as per the client specifications by using
SAS/GRAPHS, SAS/STAT, PROC/COMPARE, PROC/REPORTS, PROC/TABULATE,
Ability to work on data migration from legacy dataset to standard CDISC SDTM, ADAM datasets or any other client specific standards.

SAS (Software)

9/2016 – 8/2018

Worked closely with the Biostatistics and Data Management teams on various clinical Trials.
● Contribute to all statistical programming deliverables ready for regulatory submissions
● Coordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the
study/studies. Make statistical programming recommendations at study level.
● Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory
submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned
drug development study/project according to specifications
● Extensively worked on Manuscripts and Ad-hoc reports as requested by the regulatory and statistician
team
● Understanding of the study Documents and Data (e.g. Study design and objectives, Endpoints, Sample size,
Randomization, Study populations, SDTM, ADAM, TLF, Statistical Analysis, and Safety).
● Reviewed CRF annotations and database data specifications
● Worked on creation of analysis datasets and tables for DMC, CSR, DSUR, PSUR publications
● Perform analyses defined in the statistical analysis plan as well as ad-hoc analyses as requested. Extracting
the data from various internal and external databases (Oracle, RAVE, Excel spreadsheets) using
SAS/ACCESS, SAS/CONNECT, SAS/INPUT, Proc Import etc.

Data Science, Datenanalyse

2/2013 – 8/2016

Worked closely with the Biostatistics and Data Management teams on various clinical Trials.
● Contribute to all statistical programming deliverables ready for regulatory submissions
● Coordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the
study/studies. Make statistical programming recommendations at study level.
● Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory
submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned
drug development study/project according to specifications
● Extensively worked on Manuscripts and Ad-hoc reports as requested by the regulatory and statistician
team
● Understanding of the study Documents and Data (e.g. Study design and objectives, Endpoints, Sample size,
Randomization, Study populations, SDTM, ADAM, TLF, Statistical Analysis, and Safety).
● Reviewed CRF annotations and database data specifications
● Worked on creation of analysis datasets and tables for DMC, CSR, DSUR, PSUR publications
● Perform analyses defined in the statistical analysis plan as well as ad-hoc analyses as requested. Extracting
the data from various internal and external databases (Oracle, RAVE, Excel spreadsheets) using
SAS/ACCESS, SAS/CONNECT, SAS/INPUT, Proc Import etc.

Data Science, Datenanalyse, SAS (Software)