PEI MA

(617) · 510 · 7968 ⋄ peima09@gmail.com

Malden ⋄ MA, USA 02148

QUALIFICATIONS SUMMARY

Technical Skills

· Hands-on experiences in statistical programming for clinical trial data, pre-clinical trial data, real-world

data, and biomarker/genomic data.

· Experiences in people management(direct report and vendors management).

· Over seven years of industry experiences in biopharma, biotechnology, pharmaceutical service com-

· Over five years of experiences in web programming using Python frameworks such as Django, Flask

and R Shiny.

· Extensive experiences in cloud computing such as AWS EC2 ECS, Aurora RDS and big data analytics.

EXPERIENCE

Foundation Medicine, Inc. Cambridge, MA February 2017 — Present

Role: Senior Data manager, Biometrics and Biomarkers, Clinical Platform

· Provide guidance and trainings to team members.

· Managing internal and external data programming activities, which includes lab process data, sample

data, biomarker, genomic data, real-world evidence data(RWE) and clinical trial data.

· Ensure that all datasets, programs, and documentation are archived and ready for regulatory submis-

· Lead in designing and implementing data platform to integrate data from multiple internal and external

data sources

· Build applications and data analytic platform based on real-world clinico-genomic database (CGDB).

The CGDB is a combination of Foundation medicine’s one of the largest consolidated genomic profiling

knowledgebases and Flatiron’s oncology clinical data.

· Using machine learning methods for precision medicine such as classify tissue origin for certain cancer

types.

· Deliver molecular information based on NGS to pharmaceutical partners and academic collaborators,

with an emphasis on accuracy and timeliness

· Involved in journal publication manuscript and conference poster preparation

development plans and scientific utilization data.

· Provide strategic input and leadership to the delivery of all technical programming and information

components of deliverables.

· Plan and program the integration of clinical data databases from multiple studies or sources/vendors.

· Lead NONMEM dataset programming support for complex trial designs such as adaptive trial designs

for important internal decision making (Go/No Go criteria).

· Lead programming support to pharmacometric modeling and simulation for deliverables to regulatory

submissions.

· Oversee the quality of all deliverables, holding partners and providers accountable for the quality of

their deliverable.

· Perform efficient programming practice to produce and/or QC CDISC or Sponsor-specific datasets and

offline listings for multiple studies.

· Successfully provided statistical programming support as a lead programmer to two phase 3 studies.

· Provided unblinded safety reports to support the Data and Safety Monitoring Board (DSMB/DMC) com-

mittee meetings.

· Responsible for import/export programming specification development, test data creation and test data

entry, import/export programming functional testing, as well as mapping specifications to support rele-

vant data standards.

· Developed statistical programs with various functionality such as SAS listings, SAS summary tables,

data mapping according to sponsor standard or CDISC standards (SDTM/AdAM), data transfering.

· Working with Data management and other function groups for data checking and problem solving.

· Providing programming support on Phase I and II studies.

· QC SDTM datasets by following CDISC SDTM Implementation Guideline and review Data Spec.

· Creating Tables, Listings, and Figures output per Statistical Analysis Plan (SAP).

· Performing parallel programming QC for Tables and Listings.

· Assisting study design, Population PK/PD modeling and particular QT (ECG) data analysis.

· Calculating sample size, managing database, comparing end-points for pre-clinical trials studies.

· Reviewed various sections of CTD for clients.

· Developing utility Macros to improve programming efficiency and consistency.

Syracuse University, New York January 2010 — May 2013

Syracuse University, Syracuse NY

Master of Science in Applied Statistics May 2013

Syracuse University, Syracuse NY

Bachelor of Science in Pharmaceutical Science July 2007

Tianjin University, Tianjin China

CERTIFICATE

SAS Certified Advanced Programmer for SAS 9 May 2014

SAS Global Certification program, SAS Institute, Cary, NC

SAS Certified Base Programmer for SAS 9 March 2014

SAS Global Certification program, SAS Institute, Cary, NC

classification, factor analysis, principal components analysis, cluster analysis

time series, forecasting, imaging processing, machine learning.

Computer Languages: Python, SQL and HTML.

SAS/STAT, SAS/SQL, SAS/ODS

Summary, Format, Import, Export, Transpose, Compare, Anova, Append,

Gplot and Gchart.

Student Award, Boron In The Americas (BORAM) XIII conference, West Lafayette, IN June 2012

Student Travel Grant, Department of Chemistry, Syracuse University, Syracuse, NY July 2011

PUBLICATIONS

burden as a companion diagnostic for combination immunotherapy in non-small cell lung cancer,

Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy269.054.

2. James X. Sun, Yali Li, Coren Milbury, Joel Skoletsky, Christine Burns, Wai-ki Yip, Jun Luo, Ninad

Dewal, Adrienne Johnson, Kyle Gowen, Jing Tong, Yuting He, Jie He, Pei Ma, Jared White, Steve

Roels, John Truesdell, Eric Peters, Houston Gilbert, Charlie Wu, Erica Schleifman, Johannes

Noe, Carl Barrett, Kenneth Thress, Suzanne Jenkins, Julia Elvin, Geoff Otto, Doron Lipson, Jef-

frey Ross, Vincent Miller, Philip Stephens, Michael Doherty, Christine Vietz. A clinically validated

Christine Vietz, James X. Sun, Yali Li. An ERBB2 follow-on companion diagnostic for clinical care

of patients with breast cancer [abstract]. In: Proceedings of the American Association for Cancer

Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer

Res 2018;78(13 Suppl):Abstract nr 1607.

4. James X. Sun, Kevin Lin, Yali Li, Kyle Gowen, Yuting He, Coren Milbury, Christine Burns, Jun

Luo, Steve Roels, Murtaza Mehdi, John Truesdell, Pei Ma, Lakshman Ramamurthy, Christine

Vietz, Jeri Beltman, Thomas Harding, Doron Lipson, Jeffrey Ross, Vincent Miller, Philip Stephens,

Michael Doherty, Julia Elvin. A validated diagnostic assay for identifying ovarian cancer patients

with deleterious BRCA mutations and high genomic loss of heterozygosity (LOH) [abstract]. In:

Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr

ized carborane synthesis. Inorganic Chemistry Communications, 89:78 – 82, 2018