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Nicht freigeschaltet

Principal Statistical Programmer
Graduate Degree
27

Jahre Berufserfahrung

letzte Positionen Manager Programming, Senior Statistical Programmer, Senior Clinical Programmer | Clinical Programmer
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Beruflicher Werdegang

02.2021 - heute
Unternehmen:
Nicht freigeschaltet
Position: Principal Statistical Programmer
    Tätigkeiten:
  • Acting as point of contact for studies that are at risk in terms of quality or regarding tight timelines, incl. ad hoc debugging
  • Developing programs for datasets, tables, and listings in CDISC SDTM or ADaM format
  • Conducting ad hoc analyses requested by clients or FDA
  • Mentoring lead programmers in conducting clinical trials, incl. review and approval of outputs, specifications, and documents for deliveries
  • Developing macro templates for validation of narratives to support Medical Writing in drug safety reporting
08.2019 - 01.2021
Unternehmen:
Nicht freigeschaltet
Position: Manager Programming
    Tätigkeiten:
  • Planned resources for the assigned clinical trials midterm and for ad hoc requests
  • Oversaw programming activities
  • Supported lead programmers
  • Conducted financial reviews of projects and controlled tasks in terms of scope and budget
  • Performed risk assessment
  • Managed and mentored a team of 7 statistical programmers
  • Established and maintained client relationships
04.2014 - 07.2019
Unternehmen:
Nicht freigeschaltet
Position: Senior Statistical Programmer
    Tätigkeiten:
  • Programmed tables, lists, and graphics for the Clinical Study Report as well as derived data sets utilising SAS, incl. CDISC ADaM format
  • Programmed integrated databases and integrated safety and efficiency analyses (ISS, ISE) utilising SAS according to CDISC SDTM and ADaM standards
  • Developed ah-hoc programmes utilising SAS
  • Supervised the programming team, incl. planning, coordination, and assignment of tasks
  • Monitored timelines and budgets
  • Wrote and reviewed specifications for SDTM and ADaM
  • Led and supported single study analyses in cooperation with data managers, statisticians, and project managers
  • Acted as subject matter expert (SME) for SDTM and ADaM Define.xml
04.2004 - 03.2014
Unternehmen:
Nicht freigeschaltet
Position: Senior Clinical Programmer | Clinical Programmer
    Tätigkeiten:
  • Participated in and led clinical trials through phases II to IV in both database programming and analysis programming in various therapeutic areas
  • Set up and maintained the SAS based data entry system
  • Imported external data into the clinical database
  • Programmed data validation checks, reconciliation reports, analysis datasets, listings, and statistical tables
  • Converted source data sets into target format specified by the customer
  • Developed tools using SAS to improve process efficiency
  • Conducted quality control of programs and outputs
  • Wrote and maintained standard operating procedures (SOPs) and documentation for the statistical analysis plan
11.2003 - 12.2003
Unternehmen:
Nicht freigeschaltet
Position: Medical Documentalist | Coordination Centre for Clinical Trials: Biometrics and Data Management
    Tätigkeiten:
  • -
03.2001 - 08.2001
Unternehmen:
Nicht freigeschaltet
Position: Intern | Biometrics
    Tätigkeiten:
  • -
03.1996 - 08.1999
Unternehmen:
Nicht freigeschaltet
Position: Pharmaceutical Assistant | Pharmaceutical Advice Centre
    Tätigkeiten:
  • -
10.1995 - 02.1996
Unternehmen:
Nicht freigeschaltet
Position: Pharmacy Technician
    Tätigkeiten:
  • -
05.1990 - 08.1990
Unternehmen:
Nicht freigeschaltet
Position: Temporary Employee | Research Laboratory for Adhesives
    Tätigkeiten:
  • -
09.1988 - 03.1990
Unternehmen:
Nicht freigeschaltet
Position: Pharmacy Technician
    Tätigkeiten:
  • -
07.1988 - 08.1988
Unternehmen:
Nicht freigeschaltet
Position: Pharmacy Technician
    Tätigkeiten:
  • -

Bildung

09.1999 - 08.2003
Abschluss: Graduate Degree
Fachrichtung: Documentation in the Life Sciences; Majors: Statistics, SAS Programming (Base, Macro, Graph, Stat); - Thesis: “Statistical Methods for the Evaluation and Analysis of Laboratory Data – the Analysis of Skewed Distributions: Development, Validation and Documentation of SAS Macros for Graphic and Tabular Representation of Asymmetrically Distributed Data”
Institut:
Nicht freigeschaltet
Note: -
09.1990 - 04.1995
Abschluss: Graduate Degree
Fachrichtung: Chemical Engineering; Major: Instrumental Analysis; Thesis: “Experiments in the Determination of the Pesticide Glyphosphate in Drinking Water Using Gas Chromatography”
Institut:
Nicht freigeschaltet
Note: -
09.1985 - 03.1988
Abschluss: Apprenticeship
Fachrichtung: Pharmacy Technician
Institut:
Nicht freigeschaltet
Note: Certified by the Chamber of Pharmacists
08.1975 - 08.1985
Abschluss: General University Entrance Qualification
Fachrichtung: -
Institut:
Nicht freigeschaltet
Note: -

IT-Kenntnisse

SAS

Word

Excel

PowerPoint

Outlook

Database design

SQL

Sprachkenntnisse

Interessen

guitar playing

choral music

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