SAS Oncology Programmer
- Verfügbarkeit einsehen
- 0 Referenzen
- 95€/Stunde
- N87PD London
- Europa
- en
- 27.08.2023
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
7/2021 – offen
Tätigkeitsbeschreibung
Responsible for QC and development of SDTM and ADAM Datasets and
TLF Programming For their BLA submission for Eosinophilic Esophagitis
Statistiken, SAS (Software)
3/2020 – 7/2021
TätigkeitsbeschreibungCRO 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 QualifikationenStatistiken, SAS (Software)
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
Statistiken, SAS (Software)
3/2018 – 7/2018
TätigkeitsbeschreibungSAS 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 QualifikationenSAS (Software), Statistiken
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
SAS (Software)
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
SAS (Software), UNIX
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.
SAS (Software), UNIX
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.
SAS (Software), UNIX
10/2012 – 4/2013
TätigkeitsbeschreibungProducing 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 QualifikationenSAS (Software), Statistische Versuchsplanung (SVP)
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
SAS (Software)
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.
SAS (Software), Statistische Versuchsplanung (SVP)
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.
SAS (Software), Statistische Versuchsplanung (SVP)
Ausbildung
Atlanta, GA
Atlanta, GA USA
Über mich
Persönliche Daten
- Englisch (Muttersprache)
- Europäische Union
- Schweiz
- Vereinigte Staaten von Amerika
Kontaktdaten
Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.
Jetzt Mitglied werden