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

freiberufler Senior Statistical Programmer |SAS|CDISC|SDTM|ADAM|UNIX auf freelance.de
Referenzen
offline
DACH-Region
en  |  hi  |  de
40€/Stunde
65931 Frankfurt am Main
10.07.2019

Kurzvorstellung

Versatile, SAS Certified, Senior Statistical Programmer with 6.5 years of experience in statistical/SAS programming in
clinical domain,PhaseI-IV of clinical trials, with an extensive knowledge of SDTM, ADAM CDISC standards.

Ich biete

IT, Entwicklung
  • SAS (Software)
Forschung, Wissenschaft, Bildung
  • Data Science
  • Good clinical practice (GCP)

Fokus
  • statistical
  • Clinical SAS Programming
  • Statistical Programming
  • CDISC standards (CDASH, SDTM, ADaM)
  • edit check programming
  • Data Analysis
  • Tables, Figures and Listings (TFLs)

Projekt‐ & Berufserfahrung

Senior statistical Programmer (Festanstellung)
Kundenname anonymisiert, Pune
9/2018 – 6/2019 (10 Monate)
Life Sciences
Tätigkeitszeitraum

9/2018 – 6/2019

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

SAS (Software)


Statistical Programmer (Festanstellung)
Kundenname anonymisiert, Hyderabad
9/2016 – 8/2018 (2 Jahre)
Life Sciences
Tätigkeitszeitraum

9/2016 – 8/2018

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Data Science, Datenanalyse


Programmer/I/II (Festanstellung)
Kundenname anonymisiert, Bangalore
2/2013 – 8/2016 (3 Jahre, 7 Monate)
Life Sciences
Tätigkeitszeitraum

2/2013 – 8/2016

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Data Science, Datenanalyse, SAS (Software)

Zertifikate

BASE SAS
September 2014

Ausbildung

BASE SAS
(Ausbildung)
Jahr: 2014
Ort: India

Qualifikationen

Bachelor of Engineering

Über mich

Versatile, SAS Certified, Senior Statistical Programmer with 6.5 years of experience in statistical/SAS programming in
clinical domain,PhaseI-IV of clinical trials, with an extensive knowledge of SDTM, ADAM CDISC standards and
in-depth knowledge of clinical research regulatory requirements (GCP & ICH guidelines), Seeking an opportunity
where I can Design and develop statistical programs, with my strong analytical mind set and in-depth
knowledge/experience on SAS macro language, SAS Graph, SDTM, ADAM and pharmaceutical/clinical trial projects
knowledge and to have a huge variety of tasks and great opportunities to learn and engage in a strong scientific
community.

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Hindi (Muttersprache)
  • Deutsch (Grundkenntnisse)
Reisebereitschaft
DACH-Region
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
621
Alter
30
Berufserfahrung
7 Jahre und 9 Monate (seit 02/2013)
Projektleitung
5 Jahre

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