Resume

Sign in

Data Quality

Location:
El Granada, CA
Posted:
October 07, 2018

Contact this candidate

Resume:

XIAOYU LIU

Address: **** **** ***., *** *********, CA 94116

Tel: 908-***-****, Email: ac7a5o@r.postjobfree.com

OBJECTIVE

To seek a challenging position that will utilize my over 15 years of pharma industry experiences and strong skills in quantitative analysis of data, SAS programming, global standard tools/macros development and team management.

SUMMARY OF SKILLS

● Strong skills with Base SAS (Data steps, Procedures and MACROs, etc.), SAS/STAT,

SAS/GRAPH, ODS and SQL.

● Over 15 years of pharma industry experiences, including Pfizer CDARS experience. Worked

on studies from Phase I to IV trials on different therapeutic areas, such as oncology, vaccine,

CNS, infectious disease and CKD.

● Extensive experiences on CDISC standards and MDR (Metadata Repository). Create SDTM

& ADaM data specifications and develop macros & programs to make SDTM & ADaM data.

● Strong statistical background, including ANOVA, Regression analysis, Survival analysis,

Categorical analysis, Longitudinal data analysis and slope analysis. Using MIXED, GLM,

GENMOD, LOGISTIC, LIFETEST, PHREG and MI.

● Leadership skills and ability to manage multiple projects and to develop global standard tools

to improve the programming efficiency and quality.

PROFESSIONAL EXPERIENCES

FibroGen Inc.

Senior Manager of Statistical programming 10/2017-Present

Biometrics Department

● Review CRFs, SAP, ADaM/SDTM data specs, and CSR safety and efficacy TFLs.

● Create analysis data and TFL specifications, QC documents, and validation plans.

● Conduct independent validations for SDTM/ADaM data and CSR TFLs.

● Develop SAS programs/macros to make analysis datasets and TFLs for the primary and

secondary endpoint analyses.

● Perform statistical programming for advanced statistical methodologies, like slope analysis.

● Generate analysis data for ISS/ISE, make data integrations, and fit statistical models

● Develop innovative methods and procedures to improve the programming quality and

efficiency.

● Lead and coordinate the statistical programming activities and validations for phase III clinical

Trials.

● Contribute to the development of team utilities, processes and procedures.

● Create data review reports for data cleaning purpose and independent ad-hoc reports.

Novartis Pharmaceutical Corporation Oncology Support

Data Analytics & Science, BDM Operations

Senior Group Head 4/2016 – 9/2017

Group Head 12/2013 – 3/2016

● Create SAP and table shells. Develop listings, tables and graphs for ISS/ISE in NDA e-submission.

● Map legacy data to SDTM data. Make lab unit conversions and generate CTCAE grades.

● Review eCRFs and annotated CRFs. Follow CDISC guidelines to create SDTM & ADaM data specifications and develop macros & programs to make SDTM & ADaM datasets.

● Lead team for standard global tool designs & development, process improvements and integration.

● Develop global standard macros for statistical and data review tools, like patient profiles and CSR narratives.

● Provide management for a programming team and lead multiple projects. Mentor and guide junior associates, contractors and FSPs. Oversee CRO’s activities. Develop tools to check the data quality from CROs and to make sure the data follow Novartis and CDISC guidelines.

● Develop the guidelines/manuals and SOP for standard macros and provide the trainings.

● Make standard macros for different oncology/immune-onc assessments, like RECIST, RANO, irRC, Macdonald, Cheson, etc.

● Maintain data review tools in Jreview/Spotfire and SAS and troubleshoot the potential issues, such as database, system and programming issues.

● Establish comprehensive Excel & RTF reports with hyperlinks. Advanced use of MS Excel.

● Perform data extraction, aggregation, data issue checking, and analysis from multiple sources.

Novartis Pharmaceutical Corporation Oncology Support, CDRR/ BDM Operations

Expert Programmer 9/2008 – 11/2013

Senior Programmer 3/2006 – 8/2008

● Worked on database design and development. Review and make CRFs.

● Work on report and data standardization for oncology. Develop tools and SAS macros.

● Coaching & trainings other programmers in different sites.

● Develop patient profiles on GPS, IReview and PC. Explore new methods and procedures.

Lead and provide full in-house development support.

● Create monitoring reports for data cleaning on GPS, IReview and PC

● Discuss with statisticians, clinical trial leaders and data managers for making specifications of

protocol deviations and create protocol deviation reports on GPS, IReview and PC

● Import data to GPS from database and create analysis datasets

Outsource Group for GSK, Clinforce Inc. - Philadelphia

Senior Clinical Statistical Programmer, 6/2005 – 3/2006

● Lead programmer to create tables, listings and graphs, coordinate validations with backup

programmers and interact with statisticians and data managers.

● Create derived data sets, conduct data cleaning and report findings to management to assure

accuracy and consistency.

● Review CRF, RAP and design table shells.

● Conduct statistical analyses.

● Develop some tools and SAS macros on UNIX/HARP and /or Windows XP.

Medimmune, Inc. - Clinical Trial Design and Analysis Dept.

Clinical Data Analyst III, 9/2004 – 6/2005

Worked on Phase III studies for new flu vaccines in Immunology Therapeutic Area.

● Extracted raw data from Oracle Clinical, created analysis data sets and Wrote SAS macros to

do data cleaning and generated data listings.

● Developed SAS macros and carried out data analysis to make tables, figures, statistical

summaries for FDA submission.

● Coordinated the discussion and documented the programming related comments for the table

review meetings.

● Provided input in case report form design, database structure design and implementation.

Reviewed statistical analysis plan and table design.

PRA International (CRO) – Biostatistics Dept.

Analysis programmer II, 9/2002 – 8/2004

Working on phase II to phase IV clinical trials for different pharmaceutical companies, such as Amgen, Vicuron, Maxim, Micrologix, Shire and McNeil Consumer & Specialty. Therapeutic experience: central nervous system, oncology, infectious disease and dermatology.

● Reviewed protocols, annotated case report forms and other relevant documents.

Design tables, listings and figures programming templates.

● Conducted data cleaning and resolved data discrepancies with data management staffs.

Created derived data sets using SQL.

● Generated, reviewed and validated tables, listings and graphs according Protocols and SAPs.

● Created and modified SAS Macros to improve program’s efficiency.

● Carried out various statistical analyses (FREQ, MIXED, GLM, TTEST, LIFETEST, PHREG,

GENMOD, etc.).

● Wrote, documented, and performed quality control review of programs.

Software Technical Services, Inc.

Contractor in Pfizer Inc. – Statistical Analysis and Reporting (StAR) Dept.

SAS/Statistical Programmer, 7/2001 – 8/2002

Worked on Central Nervous System (CNS), Phase I clinical trial.

● According to protocol, made Development Operations Reporting Plan (DORP)

which included programming algorithms, programming procedures, mock

tables/figures, QC processes, documentations and TOC, etc.

● Extracted source data from Oracle Clinical. Imported Excel files to SAS Files.

Created the derived data sets.

● According to DORP, created listings and tables using REPORT, TABULATE, etc.,

made various figures using GPLOT and GCHART, GSLIDE, GREPLAY, etc.

● Developed SAS macros to analyze various data, such as ECG, PK/PD and Vital

Signs, etc. by using MIXED, GLM, GENMOD and LOGISTIC, etc.

● Conducted quality control (QC) on the derived data sets, macro programs,

listings, tables and figures and created QC documentation.

EDUCATION

The University of Illinois at Chicago

Master of Science in Biostatistics, 2001

Awards

FibroGen Spot Award for Extra Effort June, 2018

Novartis Vision Award December, 2014

Novartis Passion. Quality. Speed. (PQS) Awards. June, 2007

The extra effort and meaningful contributions that exceed expected level of performance and responsibilities and demonstrate Passion, Quality and Speed.

Publications

● Macros to Create Quality Control (QC) Documents - PharmaSUG annual meeting 2006, Bonita, Springs, Florida.

● Poster in Novartis OGD: Enabling the Organization to Deliver June 19, 2007

Patient Profiles Using JReview/I-Review)

● Methods for Flexibly Controlling Combined and Customized Outputs - PharmaSUG annual meeting 2008, Atlanta, Georgia.

● Types of Exception Reports for Oncology Clinical Trial Data and SAS Skills – NESUG annual meeting, 2011, Portland, Maine.

● How to Create High Level Data Review Tools – NESUG annual meeting, 2013, Burlington, Vermont.

● Creating Customized Graphs for Oncology Lab Parameters - PharmaSUG annual meeting 2016, Denver, Colorado



Contact this candidate