June 2021 – Feb 2023SAS programmer working remotely from the San Francisco. Responsible for QC and development of SDTM and ADAM Datasets and TLF Programming For their BLA submission for Eosinophilic Esophagitis

Working Remotely from the US.Responsibilities include: CRO oversight and QC of biostatisticalDeliverables, 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.

Working Remotely from San Francisco with 1 week per month in Switzerland.SAS Statistical Programming for Bioequivalence trials (PK and efficacy) for Autoimmune and Oncology. Responsibilities include: CRO Oversight, management of statistical programming deliverables, management of their Validated SAS Server, and management of their e-submissions process for Biostatistical Data.

This was a remote position, working from San Francisco. Responsibilities include Development and QC of ADAM datasets for Oncology Phase 3 Survival Trials for Avelumab, primarily NSCLC (Non Small Cell Lung Cancer).

Responsibilities include: 1) Producing SDTM and ADAM datasets for phase 3 Oncology clinical trials2) Producing tables, listings and graphs for phase 3 oncology clinical trials, including safety and efficacy tables.

Responsibilities include 1) Producing SDTM and ADAM datasets for a (Diabetes-Related) phase 3 Cardiovascular Outcomes trial.

I work remotely for Omeros, advising them on CDISC implementation and doing verification for their current phase 2 and phase 3 Clinical Trials

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.

Statistical programming for Phase 3 Oncology Clinical Trials, including SDTM/ADAM, and TLF programming.

I'm working on a CDISC Implementation for their Phase 3 Clinical Trial for Multiple Myeloma

Responsibilities include 1) Producing SDTM and ADAM datasets for phase 3 Oncology clinical trials2) Producing tables, listings and graphs for phase 3 oncology clinical trials, including safety and efficacy tables.3) Producing Edit Check Listings

Responsibilities include 1) Producing SDTM and ADAM datasets for phase 2 and phase 3 clinical trials2) 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 Listings5) Producing Lab reconciliation listings.

1) Producing analysis datasets for phase 3 Oncology clinical trials2) Producing tables, listings and graphs for phase 3 clinical trials, including safety and efficacy tables.3) Designing Macros and Reporting Systems for Clinical Trials

Responsibilities include: 1) Producing analysis datasets for phase 2 clinical trials, including Adam Datasets2) Producing tables, listings and graphs for phase 2 clinical trials, including safety and efficacy tables.3) Designing Macros and Reporting Systems for Clinical Trials4)Translating Clinical Data to Adam and SDTM 3.1 standards.