Statistical Programming I-Iii

Dewei Li

(Phone: 858-***-****, 619-***-****)

(Email: ***********@*****.***)

Work Experiences:

****, * - ****, * **********, Statistical Programming

Data spring Corp

1.Working on data creation for SDTM/ADAM including specification development and data generation.

2.Working on tables, listings and figures creation based on SAP and the shells.

2018, 9 – 2024, 3 Manager, Statistical Programming

Atara Biotherapeutics

1.Working on the oncology studies (phase I-III) for the biotherapy of Solid Organ Transplant (SOT) Patients with EBV-Associated Post Transplant Lymphoproliferative Disease (EBV-PTLD) after Failure of Rituximab or Rituximab and Chemotherapy.

2.Supervising/guiding the programmers for their programming tasks.

3.Drafting/reviewing SDTM/ADAM specification and developing SDTM/AdaM data based on the study documents such as protocol, SAP, and CDISC implementation guidelines.

4.Validating SDM/ADAM data and creating the documents of reviewer’s guide, define.xml using CDISC open compliance checks/P21, spot check and independent parallel programming.

5.Writing SAS code to generate ADAM data and TFLs to support ISS/ISE and DSRU/PSUR submission.

6.Creating integrated summary of safety/efficacy (ISS/ISE) data for pooled studies.

7.Producing/validating the tables, listings, and figures.

8.Creating and maintaining Macros for Lab Unit converting and TFLs generating.

9.Skilled in Oncology Domains such as TU (Tumor Identificaion), TR (Tumor Response), and RS (Disease Response) and analysis datasets like ADTTE/ADEFF etc.

2014, 11 – 2018, 8 Principal Statistical Programmer

PharmaPace

1.Working extensively on various therapeutic areas such as cardiovascular, oncology, Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (safety and efficacy), Respiratory, Gastrointestinal and Hematology.

2.Providing programming support for different pharmaceutical companies.

3.Serving as a lead on project level and managing internal database statistical programming activities by providing broad-based statistical programming directions.

4.Developing/validating the specification/datasets of SDTM/AdaM based on protocol/SAP/CDISC implementation guidelines.

5.Creating integrated summary of safety/efficacy (ISS/ISE) data for pooled studies.

6.Producing/validating summary tables and listings for demographics, screening failures, disposition, concomitant medication, disease history, protocol deviation, AE summary tables, and Lab summary/shift tables.

7.Creating and maintaining documentation for regulatory submissions like reviewer’s guide/define.xml, and so on.

2005, 10 – 2014, 10 Manager, Statistical Programming

Allergan, Inc.

1.Working on BOTOX for facial therapy.

2.Planning, organizing, and managing statistical programming activities in support of multiple projects or one entire therapeutic area.

3.Providing leadership and/or support for creating and maintaining programs to analyze and report trial data (SDTM/AdaM).

4.Supervising the work of junior and contract programmers.

5.Reviewing, maintaining and approving study documents, programs and outputs (TFLs) of statistical programs.

2005, 2 – 2005, 10 Manager, Statistical Programming

Pfizer, Inc.

1.Working on the drug for Late-stage HIV disease (safety)Late-stage HIV disease (safety).

2.Processing clinical data required for analysis of clinical trials for marketed products, or for the production of safety reports (including projects, for which the Department has been requested to provide programming support).

3.Interacting with members of GDT and DMT product teams, statisticians and data managers to establish project timelines, computerized data validation checks and statistical analyses (safety and efficacy).

4.Developing computer software necessary for preparing, processing and analyzing clinical data, investigating new methodologies and statistical techniques for the computer processing and statistical analysis of clinical data.

2002, 11 – 2005, 1 Principal Statistical Programmer

Allergan, Inc.,

1.Working on BOTOX for facial therapy.

2.Participating in development of work flow and SOPs to streamline the Biostatistics and Statistical Programming operation.

3.Serving as lead programmer for projects in support of analysis data sets (ADS), tables, listings, and graphs (TFLs) generation.

2001, 6 – 2002, 10 Manager, Statistical Programming

Pfizer, Inc.

1.Working on the drugs for the Male erectile dysfunction (safety and efficacy) and Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (safety and efficacy).

2.Processing clinical data required for analysis of clinical trials for marketed products, or for the production of safety reports (including projects, for which the Department has been requested to provide programming support).

3. Developing analysis data and producing tables, listings, and figures.

2001, 3 – 2001, 5 Consultant, Statistical Programming

Amgen Inc.

Developing analysis data and producing tables, listings, and figures.

2000, 6 – 2001, 2 Statistical Programmer

Alliance Pharmaceutical Corp.

1.Working on the OXGEN as blood substitution.

2.Developing analysis data and producing tables, listings, and figures.

1997, 11 – 2000, 5 Statistical Programmer

Parexel International Corporation

1.Working on different therapeutical area such as Epithelial adenocarcinoma of ovarian, tubal or peritoneal origin (safety and efficacy), Secondary Hyperparathyroidism of Endstage Renal Disease (safety and efficacy), and Influenza outbreak and influenza-like illness (safety and efficacy).

2.Serving for different pharmaceutical companies.

3.Leading several projects and developing analysis data and producing tables, listings, and figures.

Technical Skills:

Statistical Software: SAS (including most of Data and Statistical Procedures), SPSS

Other Software: C++, MS-Excel, MS-Word, Windows 95 and NT

Computer System: IBN-PC, Novel-LAN, VMS, UNIX

Education:

1988 Ph.D. Educational Psychology, Capital Normal University, Beijing, China

1985 MS Psychology of Personality, Beijing Normal University, Beijing, China

1982 BS Psychology, Beijing Normal University, Beijing, China

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