SAS Oncology Programmer

3/2018 – 7/2018

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.

SAS (Software), Statistik (allg.)

2/2016 – 2/2017

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

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

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

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

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.

SAS (Software), Statistische Versuchsplanung (SVP)

11/2011 – 2/2015

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

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

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)