SUMMARY:

• SAS Programmer with over 9 years experience and strong knowledge in Base SAS, SAS/STAT, SAS Macros, SAS/GRAPH with expertise with SAS procedures Proc Tabulate, Univariate, Means, Freq, Means, Compare, sort, Transpose and Report with accordance ICH GCP Guidelines.

TECHNICAL SKILLS:

Statistical Software & Tools: SAS 8/9.1.3/9.2, SAS/BASE, SQL, SA/ GRAPH, SAS/STAT, MACROS, and MS - Excel.

Databases: Windows, Oracle, UNIX, MS SQL server 2008/2005/2000, DB2

Programming Languages: SAS Base, SAS Macros, SAS SQL

OS Software: Windows 10/8.1/7 and Windows Server 2012 R2.

PROFESSIONAL EXPERIENCE:

Confidential, New Jersey

Senior Statistical Programmer SAS

Responsibilities:

• Lead programmer for a phase II project and saw through its completion on time. The responsibilities included being a primary programmer for most of the study, doing the primary review of the specifications and finalizing them, assigning timelines and work to other programmers and performed all the Ad-hoc requests after the output submission.
• Monitor external agency (CRO) work by involving weekly meetings, review the specifications, outputs and oversee the work for timely completion of the project.
• Extensively worked in writing SDTM, ADaM specifications and also validating specifications writing by external agencies.
• Involved in generation of different regulatory (EMA, Taiwan FDA, Canada FDA) specific required outputs.
• Review SAP, CRF and annotated CRFs. Created table shells for adhoc reports.
• Generated Adhoc reports in Tables, Listings and Graphs from external data, survey data for protocol development.
• Extensively worked on Integration of Safety and Efficacy datasets along with reports.
• Worked with Data management group for data review of ongoing studies.
• Worked extensively to generate datasets, statistical reports, monthly reports, listings, safety reports for cross-functional teams for phase I and II clinical trial data for IND.
• Familiar with OpenCDISC validator report and validating the report.
• Generated pooled datasets for exploratory analysis, closely worked with statisticians on different exploratory analysis.
• Experienced in creation of outputs in different formats for different registries.
• Generated Kaplan- Meier plots. Used PROC GPLOT with appropriate graphing devices and graphing options to generate desired end results
• Experienced in study close out activities like generation and review of Define.XML, SDRG.
• Involved in DSUR, IB and Interim Analysis for different molecules.

SAS Programmer, SAS

Responsibilities:

• Locally coordinate and take responsibility for trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to support program programmers and statistician in project level activities.
• Be responsible for statistical tasks on assigned clinical trials e.g. RAP.
• Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.
• Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
• Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones.
• In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
• Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
• Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH
• Leading the marketing analytics team to support clients specific request
• Setting goals for my team and providing the annual and midterm appraisals.
• Provides SAS / Statistical programming support & advice
• Analysis of Financial Data to provide business insights.

Environment: SAS v9.4, SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS

Sr. process expert

Responsibilities:

• A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: Evaluation of the efficacy and safety of brivaracetam in subjects (≥ 16 to 70 years old) With Partial Onset Seizures
• Responsibilities:
• Worked extensively in different phases of drug development in Oncology therapeutic area.
• Locally coordinate and take responsibility for trial level programming activities (analysis Datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to Support program programmers and statistician in project level activities.
• Strong Experience on CDASH standards & OPEN CDISC review for the submission studies
• Extensively worked on creation of SDTM and ADAM datasets as per CDISC standards.
• Developed and reviewed specifications for SDTM and ADAM datasets as per CDISC standards.
• Responsible for the completion and documentation of entire project.
• Extensively involved in inter departmental meetings with Data management group, Statisticians, Medical writers and Clinical trial heads.
• Involved in review of mock shells, CRFs and data transfer specifications.
• Effectively worked in submission of adhoc outputs for different regulatory authorities.
• Program and deliver, according to specifications, analysis datasets, pooled datasets, listings,
• Tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and
• Within milestones.
• In consultation with the statistician, develop specifications for analysis datasets, pooled
• Datasets and listings.
• Enhance technical skills relevant to statistics and efficient programming aspects.

Environment: SAS v9.2, SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ODS

SAS Programmer

Responsibilities:

• An open-label, multicenter, non-randomized, dose-escalating phase I/II study, with a randomized phase II part, to investigate the safety and tolerability of RO5072759 given as immunotherapy in Patients with CD20+ alignant disease.
• Responsibilities:
• Generated summary safety tables and summary efficacy tables for FDA submission.
• Extensively used and created macros to increase ease of use and consistency.
• Extensively used BASE SAS, SAS/STAT, SAS/GRAPH and SAS MACROS to generate Tables, Listings and Graphs and performed a statistical analysis on the clinical data.
• Produced survival distribution estimation using ProcLifetest.
• Produced descriptive statistics using Proc Means, ProcUnivariate, ProcFreq
• Created documentation according to company’s requirements.
• Created analysis datasets referring to the specifications provided according to SAP.
• Produced efficacy datasets and analysis reports using LOCF approach.
• Performed validation programming & edit checks on clinical trial data.
• Developed routine SAS macros to create tables, and listings for inclusion in clinical study reports and regulatory submissions and also maintained the existing reports.
• Developed Data Definition Tables (DDT) for FDA submission according to CDISC mapping and protocol specifications.
• Created graphs by using the SAS annotate facility and SAS/GRAPH procedures like PROC GCHART and PROC GPLOT.
• Developed SAS programs for correlations and check for dispersion of normality.
• Used Data Null technique for producing customized reports.
• Created PS, PDF, HTML and RTF output by using SAS ODS. Validated SAS program to ensure SOP compliance.

Environment: SAS v9.1.3, SAS Enterprise Guide, SAS Base, SAS/SQL, SAS/MACROS

SAS Programmer

Responsibilities:

• A single center, open label, single dose, dose proportionality non-controlled Phase I study in healthy Japanese male volunteers. Objective is to examine pharmacokinetics and dose proportionality safety and tolerability after administration of NKQ-01
• Responsibilities:
• Created database conversion programs for clinical studies according to the Data Management Plan (DMP), tracked each receipt of non-CRF data, assisted in the process of locking & freezing databases, sent interim, frozen and final databases to client.
• Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician.
• Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
• Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones.
• In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
• Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
• Generate Reports and Tabular Reports using Proc Report and Proc Tabulate.

Environment: SAS v8, SAS Enterprise Guide, SAS Base, SAS/SQL, SAS/MACROS, SAS/STAT