freiberufler SAS Oncology Programmer auf freelance.de

SAS Oncology Programmer

offline
  • 95€/Stunde
  • N87PD London
  • Europa
  • en
  • 27.08.2023

Kurzvorstellung

SAS programming in Pharmaceutical Clinical Trials, with statistical skills specific to oncology.

Qualifikationen

  • SAS (Software)13 J.
  • Statistiken6 J.
  • Statistische Versuchsplanung (SVP)2 J.

Projekt‐ & Berufserfahrung

Statistical Programmer
Ellodi Pharmaceuticals, Lawrenceville, New Jersey
7/2021 – offen (3 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

7/2021 – offen

Tätigkeitsbeschreibung

Responsible for QC and development of SDTM and ADAM Datasets and
TLF Programming For their BLA submission for Eosinophilic Esophagitis

Eingesetzte Qualifikationen

Statistiken, SAS (Software)

Statistical Consultant
Biontech SE, Mainz
3/2020 – 7/2021 (1 Jahr, 5 Monate)
Life Sciences
Tätigkeitszeitraum

3/2020 – 7/2021

Tätigkeitsbeschreibung

CRO oversight and QC of biostatistical Deliverables, Development of Validation plan for their SAS Server, Development of a Standard Clinical Study and programming environment, and management of the alignment with Pfizer for a co-sponsorship of their new COVID-19 vaccine.

Eingesetzte Qualifikationen

Statistiken, SAS (Software)

Statistical Programming Manager
Fresenius-Kabi Biosimilars, Geneva
2/2019 – 3/2020 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

2/2019 – 3/2020

Tätigkeitsbeschreibung

SAS Statistical Programming for Bioequivalence trials (PK and
efficacy) for Autoimmune and Oncology. CRO Oversight and
management of statistical programming deliverables. Also responsible
for Biostats submission activities, preparing the e-submission and
answering post-submission FDA questions

Eingesetzte Qualifikationen

Statistiken, SAS (Software)

Oncology Programmer
Merck, Darmstadt
3/2018 – 7/2018 (5 Monate)
Life Sciences
Tätigkeitszeitraum

3/2018 – 7/2018

Tätigkeitsbeschreibung

SAS Statistical Programming for Oncology Phase 3 Survival Trial For Avelumab NSCLC NDA and ISS Submission. Efficacy Failed for Lung Submission, so programming for Safety only. SDTM ADAM and TLFs.

Eingesetzte Qualifikationen

SAS (Software), Statistiken

Senior Statistical Programmer
Novartis, Basel
2/2016 – 2/2017 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

2/2016 – 2/2017

Tätigkeitsbeschreibung

SAS Statistical Programmer for Oncology Phase 3 Survival Trial
for Ribociclib Metastatic Breast Cancer NDA and ISS/ISE Submission.
Safety and Efficacy. SDTM ADAM and TLFs

Eingesetzte Qualifikationen

SAS (Software)

SAS CDISC Programmer
Novo Nordisk, Copenhagen
10/2014 – 1/2016 (1 Jahr, 4 Monate)
Life Sciences
Tätigkeitszeitraum

10/2014 – 1/2016

Tätigkeitsbeschreibung

I am working on a SDTM generation project for several of Novo’s long-term Safety Trials for
Diabetes. My responsibilities include creating SDTM, ADAM, and Define.xml and the reviewers guide for the studies

Eingesetzte Qualifikationen

SAS (Software), UNIX

SAS Oncology Programmer
Merck Sharpe Dohme, Brussels
3/2014 – 10/2014 (8 Monate)
Life Sciences
Tätigkeitszeitraum

3/2014 – 10/2014

Tätigkeitsbeschreibung

Oncology programmer for MSD’s partnership with Endocyte for Platinum-Resistent
Ovarian Cancer. My role was to provide QC of existing data and TLF’s as well as providing additional analysis. Additionally I have also been working on a long-term safety study for one of Merck’s Osteoporosis products.

Eingesetzte Qualifikationen

SAS (Software), UNIX

SAS Oncology Programmer
Roche, London
5/2013 – 11/2013 (7 Monate)
Life Sciences
Tätigkeitszeitraum

5/2013 – 11/2013

Tätigkeitsbeschreibung

The Roche site in the UK has taken over many of Genentech’s Oncology products (since the merger several years ago) and are doing the statistical programming for ongoing clinical trials for Avastin and Herceptin.
My role is as Production programmer for the efficacy analysis datasets (Tumor Response and Time-to-Event) for an ongoing Herceptin Breast Cancer Phase 3 Survival Trial, and as QC programmer for many of the safety datasets, tables and listings.

Eingesetzte Qualifikationen

SAS (Software), UNIX

SAS Oncology Programmer
Threshold Pharmaceuticals, San Francisco
10/2012 – 4/2013 (7 Monate)
Life Sciences
Tätigkeitszeitraum

10/2012 – 4/2013

Tätigkeitsbeschreibung

Producing SDTM and ADAM datasets, tlfs, and define.xml, and assisting medical writers with in-text tables for a submission involving 8 oncology trials phase 1-3. A Phase 3 Pancreatic Cancer trial is ongoing.

Eingesetzte Qualifikationen

SAS (Software), Statistische Versuchsplanung (SVP)

SAS SDTM Subject Matter Expert
Omeros, Seattle
11/2011 – 2/2015 (3 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

11/2011 – 2/2015

Tätigkeitsbeschreibung

Working Remotely . . .
1) Producing SDTM and ADAM (or QC datasets) for phase 3 clinical trials
for their surgical pupil dialation/anti inflammatory product OMS302, and for their Anti-Psychotic
treatment OMS824
2) Producing tables, listings and graphs for phase 3 clinical trials, including safety and efficacy
tables.
3) Producing Define.xml and Reviewers Guide

Eingesetzte Qualifikationen

SAS (Software)

SAS Oncology CDISC Programmer
Medivation, San Francisco
8/2010 – 9/2011 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

8/2010 – 9/2011

Tätigkeitsbeschreibung

Responsibilities include
1) Producing SDTM and ADAM datasets for phase 3 clinical trials, including one Clinical Trial for Huntington’s disease (Dimebon), and another for prostate cancer (MDV3100 Affirm).

2) Producing tables, listings and graphs for phase 3 clinical trials, including safety and efficacy tables.

Eingesetzte Qualifikationen

SAS (Software), Statistische Versuchsplanung (SVP)

SAS Statistical Programmer
Affymax, Palo Alto
11/2009 – 8/2010 (10 Monate)
Life Sciences
Tätigkeitszeitraum

11/2009 – 8/2010

Tätigkeitsbeschreibung

1) Producing SDTM and ADAM datasets for phase 2 and phase 3 clinical trials
2) Producing tables, listings and graphs for phase 2 and phase 3 clinical trials, including safety and efficacy tables.
3) Producing tables, listings and graphs for the ISS and ISE (Integrated Safety Summary and Integrated Summary of Efficacy) which encompasses several Phase 2 and Phase 3 Studies.
4) Producing Edit Check Listings
5) Producing Lab reconciliation listings.

Eingesetzte Qualifikationen

SAS (Software), Statistische Versuchsplanung (SVP)

Ausbildung

Master of Science in Statistics
Ausbildung
1997
Atlanta, GA
Bachelor of Science in Statistics
Ausbildung
1990
Atlanta, GA USA

Über mich

Dual Nationality Irish and USA

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
  • Vereinigte Staaten von Amerika
Profilaufrufe
2182
Alter
59
Berufserfahrung
20 Jahre und 9 Monate (seit 02/2004)
Projektleitung
3 Jahre

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