Consultant Senior Statistical Programmer

• Sep 2020 - Present

Using EDC Sas Grid & Sas Enterprise Guide 7.1 to program TLFs in NSCLC /BTC / Cervical Oncology on 3 Studies, for Merck-Serono (MS) Biostats to MS Adam 2.3. Specifications supporting Adam IG 1.1-1.2 , Sdtm 3.2 & Define XML 2.0 + ARM. Creating Merck specs & Qcing , programming datasets under wide complex metadata namely ADSL , ADLB/BIOM /CHEM/HEMA , ADEX, ADDV whilst simultaneously data mining for data issues. Creating, writing and reviewing Annotated Shells. Use Iqvia bespoke analysis & reporting automation tool :GENIE v2.3 to produce TLFs.

Consultant Statistical Programmer

• Sep 2019 - Sep 2020

-ADRG editing & review. -Qcing oncology displays in MM disease area across multiple reporting efforts. -Programming/Creating ODS reports to compare differences in numerous Datasets & Displays in 2 libraries @ a Higher & detailed level. - Advisory role on subgroup analysis. Phase II Submission qc. Phase I Dose escalation qc. Define & Pinnacle 21. - ISS integration & Production development (Respiratory)

Senior Statistical Programmer

• Aug 2018 - Sep 2019

Programming on Non Small Cell Lung Cancer & Multiple Myeloma studies, setup in Oncology R&D. TLG QC. Supporting Managers & Directors in building a new Uk programming hub in Oncology for systems & the programming environment. Interrogating Adam metadata & spec. QCing Adam macros. Running exhaustive data checks on SDTM data. QCing Box-plots/Scatter-plots, using Proc SGPlot SAS 9.4. Testing Regression, Dot plots and Scatter Panelling. QCing Tables eg Pharmacokinetic , AE, Exposure. Reviewing draft submission material, i.e ADRG, Supplemental Definitions, define.pdf.Qcing Efficacy tables; Best ORR, per Computerised Algorithm’s including to CI’s , Relative Risk, p-values , Hazard ratios.Aiding the Safety Management team & Director in identifying ADR’s important for labelling. Producing SCE tables across studies.Adhoc production & QC for FDA , Japan PMDA, Taiwan & Canada regulatory agencies.

Project Programmer

• Jul 2017 - Jul 2018

ADaM Trial programmer for Novartis Oncology via DOCs an ICON subsidiary. Organising regular weekly meetings with client , ensuring future submissions being timely for biomarker breast cancer studies within the portfolio. Programming ADAM datasets/displays as per ADAM specification and regularly communicating with validator and spec writer regarding logic and attention to detail e.g on ADTTE, ADLB, ADVS, ADEG performing code iterations.

Senior Programmer Analyst

• Sep 2013 - Jul 2017

Senior Programmer Analyst

• Mar 2015 - Jun 2017

Over-sighting Parkinson's, Ophthalmology Studies with functional service providers (CROs). Producing in house safety displays for Lupus studies and graphical production using in house macros. QC - Quality check ADD studies and dermatology studies. Production and QC of epilepsy data sets. Use Spotfire regularly as graphical data visualization tool to aid Clinical Development scientists to make informed decisions by devising self-dynamic SAS code to aid Risk based monitoring. Reporting Disclosure displays as per FDAAA requirements . Annual DSUR reporting. Use SAS Linux 9.4 / PC-SAS and increasingly : SAS Studio 3.5.

Programmer/Analyst

• Aug 2008 - Sep 2013

Statistical Programmer

• Jul 2007 - Aug 2008

QC in Respiratory, Psychiatric and Diabetes Studies, Meta- analyses on 54 pooled HIV studies evaluating CVS Risk and relative risk . SAS Checks with client (Astra- Zeneca). Producing Tables and Listings.

Clinical Data Manager

• Jan 2007 - Jul 2007

Oracle Clintrial, Inform 4.1, UAT, QC

IT Trainer

• May 2001 - Nov 2006

Motivating and teaching adults in Microsoft applications through tutorials , workshops, 1:1 sessions and workbooks. Students would be of various backgrounds and all walks of life, so it was essential to have a 'humanistic' approach and deep understanding of individual needs. Role entailed marking assessments, tailoring effective workshops, using IT technical solutions and awareness.