OBJECTIVE

• Senior statistical programmer position in Pharmaceutical/Biotechnology Company or Clinical Research Organization (CRO)

SUMMARY

• 6 years’ solid experience in statistical programming in pharmaceutical/CRO industry, proven ability and effectiveness in statistical programming on Phase I - IV clinical trials and publications;
• Extensive experience in handling clinical trials data by following CDISC SDTM ADaM guideline; experienced in data mapping via eCRF and specifications for SDTM dataset from normalized raw data and ADaM dataset from SDTM dataset; experienced in generating and validating normalized raw data from EDC raw dataset with cooperation of data management group
• Excellent hands-on experience in SAS coding, including SAS/BASE, SAS/MACRO, SQL Language, SAS/STAT, SAS/ODS and SAS/GRAPH; proficient in generating TLGs by following standard table shells in studies’ SAPs or producing customized TLGs for various ad-hoc requests by applying output procedure like PROC REPORT, PROC GPLOT, PROC GCHART etc.
• Stay independency during validation procedure and skilled in communicating with statisticians and principal programmers when discrepancies exist and solving the issues
• Proficient in learning, applying, developing and modifying Macros to produce standard TLGs and analysis datasets for subgroup analysis; Self-developed SAS DDE (Dynamic Data Exchange) Macros interact SAS dataset with external Microsoft Excel sources via SAS programs; directed SAS outputs into customized RTF, PDF or HTML format files through SAS/ODS
• Background with Minor Master’s degree in Statistics, solid knowledge and understanding in linear regressions, categorical data analyses, time series analyses, survival analyses, parametric statistics, etc.; experienced in applying SAS statistical procedures, typically like PROC UNIVARIATE/GLM/LOGISTIC/PHREG/LIFETEST, to generate statistical analyses outputs upon statisticians’ requests; sufficient experience in oncology studies include producing and validating PFS, OS tables and figures and following RECIST 1.1 guideline to assess the change to tumor burden when deriving analysis efficacy datasets
• Good interpersonal, communication, problem solving, and analytical skills; work independently with minimum or none supervision; ability to collaborate and communicate with cross-functional team members; flexible and excellent ability to work on multiple studies with competing priorities

TECHNICAL SKILLS

• SQL
• MATLAB
• C/C++ Language
• R Language
• Minitab
• Advanced skill in Microsoft Excel
• Microsoft Office Suite
• SAS Universal Viewer

PROFESSIONAL EXPERIENCE

Confidential, Woodcliff Lake, NJ

Sr. Biostat Programmer

Responsibilities:

• Review protocols, statistical analysis plans and case report forms, and provide statistical programming and validation support for clinical study reports;
• Responsible for the implementation of SAS programming to search for recurring patterns through large volume of data;
• Create and validate customized statistical summary outputs including tables, listings and graphs (TLGs) upon ad-hoc analysis request; review and modify existing SAS programs and Macros to produce standard TLGs or their subgroup analyses outputs;
• Pull data from multiple internal and external source using SAS or SQL programming language; output final SAS datasets into Microsoft Excel/RTF files for medications and adverse events reviewing purpose;
• Build normalized raw data from EDC raw data; map normalized raw dataset to SDTM and then from SDTM to ADaM datasets by following eCRF and data specifications; ensure the CDISC and company’s guidelines applied to eCRF, data SPECS and standardized datasets; program validation exercises to assure data quality;
• Identify vendor requirements and participate in the evaluation/selection of Analytical Science vendors; participate in defining vendor strategy for projects and ensure consistency in vendor management for the statistical programming part; provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs and consistency within development program or integrated safety analyses; review key statistical programming vendor deliverables.
• Pool analyses safety and efficacy datasets from 2 or more studies to generate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) datasets;
• Develop standard programs to facilitate general programming requirement Generate descriptive statistics outputs for supporting statistical analysis plans (SAP), reports and publications;
• Follow RECIST 1.1 guideline on oncology studies; perform survival analysis via obtaining hazard ratio based on regression model, estimating survival duration, survival rate and plotting survival curve using Kaplan-Meier estimate, comparing two survival curves by log-rank test via SAS program;
• Perform categorical data analyses by applying Fisher’s exact test, Pearson’s Chi-square test; implement ANOVA, ANCOVA, and linear and logistic regression models for the purpose of between groups’ comparison and measuring the relationship between the categorical dependent variable and one or more independent variables by executing PROC GLM, PROC LOGISTIC procedures;

Confidential, King of Prussia, PA

Statistical Programmer

Responsibilities:

• Supporting programmer within a study team involved in the creation and QC of analysis datasets, TLGs or standard tools following standard data models or user requirements; applied standard tools developed for studies or projects; participated in development of new standards and tools;
• Followed all company SOP and guidelines in the creation of the programming deliverables; adhered to procedures surrounding retention of data, records, and information for clinical studies;
• Self-developed SAS DDE (Dynamic Data Exchange) Macros interact SAS dataset with external Microsoft Excel sources via SAS programs; directed SAS outputs into customized RTF, PDF or HTML format files through SAS/ODS;
• Generated and validated normalized raw data, SDTM dataset and ADaM dataset based on eCRF and specifications under CDISC guideline or company’s specific requirements; edited and reviewed annotated eCRF, specifications; participated meeting with clients’ validation team for the discussion of quires in eCRF annotations and specifications and discrepancies in dataset;
• Combined studies’ safety and efficacy dataset to derive Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) datasets and create TLGS for ad-hoc requests and submission purpose;
• Produced statistical analysis output (TLGs) involving descriptive and inferential statistics to support creation of the clinical study reports, integrated results, including safety statistics deliverables and regulatory submissions, and ad-hoc and exploratory analyses; applied censoring rules and deriving PFS, OS and other time to event variables needed;
• Created new programs, troubleshoots and updates code written by colleagues in support of design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data;
• Helped maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficiency for the department;

Confidential, King of Prussia, PA

Statistical Programmer

Responsibilities:

• Used SAS software (SAS BASE/STAT/GRAPH/MACRO) for the production of well formatted datasets, tables, listings, and figures, and outputs requested per programming specifications, Statistical Analysis Plan, and other study related documentation;
• Validated normalized raw data from EDC raw data; mapped SDTM dataset from normalized raw data and ADaM dataset from standardized SDTM dataset via eCRF and specifications under company’s data standard guideline;
• Developed customized SAS Macros for various purposes; applied SAS DDE (Dynamic Data Exchange) technique to access and convert data to SAS from Database management system and PC file formats (e.g., MS Excel, text files);
• Performed Quality Control to ensure that outputs meet quality standards and project requirements; works with other programmers, biostatistician, and other project team members to resolve discrepancies or any findings;
• Reviewed project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design, and provided feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities;
• Maintained well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs in compliance with company and sponsor standards;
• Regularly attended and prepared in advance for internal meetings and contributed ideas; participated client meetings in conjunction with the project manager;
• Reviewed literatures regularly for novel and efficient technical skills, and applied to daily work;