SUMMARY:

• Nearly 6 years of SAS programming experience in Confidential / Pharmaceutical Company etc.
• Use SAS to do statistical analysis of clinical trial phase I - III.
• Good understanding of Protocol/SAP/CRF/Mock Shell.
• Develop in SAP, Mock shells and table shells.
• Proficient in analysis of Clinical Trial data and preparation of SAS datasets, TLFs and reports.
• Develop new Macros and maintain existing ones.
• Experienced with Integrated Summary of Safety and Efficacy (ISS/ISE).
• Good understanding of drug development processes, CDISC standards, CRF, MedDRA, WHODRUG, Industry SOPs and FDA submission guidelines. Support NDA Submissions.
• QA (to see the operations in organization meet regulatory standards).
• Proficient in reviewing, debugging and validating SAS programs.
• Excellent in working with multiple tasks under time pressure, and willing to take on extra responsibilities to get work done.
• CDISC Programming
• Experienced in the QC of Derived ADaM datasets, SDTM datasets following a parallel programming approach.
• Performed compliance checks on SDTM models using Open CDISC validate tool.
• Experienced in creation, modification and validation of STDM and ADaM datasets.
• Experienced in pooling the data sets across multiple studies to form the integrated analysis data sets
• Familiar with SDTM domains such as DM, AE, LB, VS, TU, TR.
• Familiar with ADaM data such as ADSL, ADAE, ADVS, ADLB, ADTTE etc.
• Familiar with Mapping specifications for SDTM domains.
• Familiar with CRF annotation in SDTM.
• Familiar with checking SDTM compliance through OPENCDISC VALODATOR.

TECHNICAL SKILLS:

Statistical Inference: Probability Theory, Principles of data Reduction, Asymptotic Evaluations, GLM, Empirical Bayes Model.

Point Estimation: MOM, MLE, Bayes Estimators, EM Algorithm.

Hypothesis Testing: Likelihood Ratio Tests, Bayesian Tests, Methods of Evaluating Tests (Most Powerful Tests / T test / F Test / 2 Test / P - Values / Loss Function Optimality).

Interval Estimation: Pivotal Quantities, CDF, Bayesian Intervals, Bootstrap Confidence Interval, Methods of Evaluating Interval (LRT / Bayesian Optimality).

Sampling Theory: Simple Random Sampling, Stratified Sampling, Cluster Sampling, Two-Phase Sampling.

Multivariate Analysis: one-way MANOVA, two-way ANOVA, Hotelling s T 2 test, Factor Analysis (factor rotation, factor scores), Cluster Analysis (k-means / K-medoid).

Analysis Tools: SAS/BASE, SAS/SQL, SAS/MACRO, SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/GLM, SAS/MIXED, SAS/REG R / MATLAB / SPSS

Other Tools: Microsoft Word, Microsoft Excel, Microsoft PowerPoint.

Platform: UNIX, Windows

PROFESSIONAL EXPERIENCE:

Confidential, MA

Responsibilities:

• Review and comment study results, and prepared statistical methods sections for clinical/statistical reports.
• Review (protocol, SAP, CRF, SOP (standard operation of procedures) etc).
• Support in producing Standard CDISC SDTM/ADaM specifications for Efficacy and Safety related domains for different therapeutic areas,including Oncology, Dermatology etc.
• Generate SDTM datadets and ADaM datasets from raw datasets.
• Import and convert datasets from different sources into SAS permanent datasets.
• Pull out data from clinical datasets and prepared customized analysis datasets for specific reporting needs.
• Perform ISS(integrated summary of safety)/ISE(integrated summary of efficacy) analysis.
• Responsible for building and validating safety/efficacy/baseline datasets per specifications and writing SAS codes, Macros and using validated Macros for generating TLFs.
• Pool the data sets across multiple studies to form the integrated analysis data sets.
• Produce CDISC SDTM domains for Phase I, II, and III studies. This includes domains for DM, AE, LB, VS, TU, TR etc.
• Generate derived data sets ADaM for ADSL, ADAE, ADVS, ADLB, ADTTE etc.
• Generate tables, listings and figures to support clinical reporting by using SAS/BASE, SAS/SQL, SAS/MACRO, SAS/GRAPH.
• Develop, implement and validate Macros for routing tables, listings and figures.
• Modify and maintain existing SAS Macros for creation of standard formatted reports and figures, generated new Macros for routine tasks.
• Write SAS codes to generate safety/efficacy/baseline CDISC SDTM domains and validate/QC project related SDTM domains.
• Contribute with QA group to see the operations in organization meet regulatory standards.
• Check that TLG follows all Statistical Analysis Plan specifications.
• Fit logistic regression model and other generalized linear models to test for association between covariates and responses by SAS.
• Develop Statistical Analysis Plan, extracted and built SAS data sets for analysis. Designed, coded and implemented SAS reports and summary tables (summary statistics, including mean, std., geometric mean, p - values and 95% confidence intervals), listings, and figures.
• Design and review mockup tables for SAP.
• Validate TLG and SAS programs for Oncology, Gastroenterology and Vaccines projects.

SAS Programmer, Data Manager

Confidential, Fort Washington, PA

Responsibilities:

• Create mapping specifications and review annotated SDTM CRF from source CRF data to meet CDISC SDTM standards/sponsor standard.
• Migrate variables to CDISC SDTM standard before they are loaded into the database.
• Produce CDISC SDTM domains for Phase I, II, and III studies including domains for DM, AE, LB, VS etc.
• Design, code and implement SAS reports (tables, listings, and graphs) by using SAS/BASE, SAS/SQL, SAS/MACRO, SAS/GRAPH.
• Develop in SAP, Mock shells and table shells for Phase I and II.
• Check SDTM compliance through OPENCDISC VALIDATOR.
• Participate in QA group to make sure that the business processes meet regulatory standards.
• Modify existing Macros and apply to multiple studies for different purposes.
• Support in producing Standard CDISC SDTM/ADaM specifications for Efficacy and Safety related domains for different therapeutic areas including Oncology, Pain Studies and Diabetes etc.
• Provide programming support in analysis of Oncology, Pain Studies and Diabetes project.
• Participate in creation and validation of integrated summaries of safety and efficacy (ISS/ISE).
• Develop all the SAS codes to generate ADaM data (ADSL, BDS, etc.).
• Generate SDTM datasets and ADaM datasets from raw datasets by the extensive use of self - created Macros.
• QC/Validate SDTM and ADaM datasets using PROC COMPARE and OpenCDISC.

SAS Programmer, Data Manager

Confidential, San Rafael, CA

Responsibilities:

• Develop mapping specifications for SDTM domains on SDTM IG.
• Create SDTM datadets from raw datasets and ADaM datasets from SDTM datasets.
• Convert different file formates (Excel, CSV) to SAS permanent datasets.
• Contribute in reviewing protocol, SAP, CRF and SOP etc.
• Pool the data sets across multiple studies to form the integrated analysis data sets.
• Generate CDISC SDTM domains (DM, AE, LB, VS, TU and TR etc) for Phase I, II, and III studies.
• Generate derived data sets (ADaM) for demographics (ADSL), adverse events (ADAE), vital signs (ADVS), labs (ADLB), Time to Event (ADTTE) etc.
• Develop SAS programs for tables, listings and figures to support clinical reporting.
• Generate efficacy and safety tables.
• Check annotated SDTM CRF to make sure that meet CDISC SDTM standards/sponsor standard.
• Work as QA group to make sure that the business processes meet regulatory standards.
• Modify existing SAS Macros to create standard reports.
• Generate new Macros for routine tasks.
• Meet with SAS Programmer, Data Manager and statistician weekly.