Amy Lin

acz3iy@r.postjobfree.com

Experience Summary:

Certified SAS professional with over 8 years of experience in the pharmaceutical and CRO industry.

Contributed to the SAS Programming activities for Phases I – IV of clinical trials, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and FDA submissions.

Contributed to multiple regulatory submissions by creating/reviewing CRT packages including SAS transport files, define.PDF documents and annotated CRFs.

Extensive experience in generating tables, listings, and graphs (TLGs) according to the statistical analysis plan (SAP).

Hands-on experience in creating and validating SDTM mapping documents and ADaM analysis dataset programming specifications.

Extensively worked on creating and validating CDISC SDTM and ADaM datasets for various domains across safety, efficacy and subject-data characteristics.

Strong experience in generating customized reports for statistical results using SAS procedures MIXED, GLM, LIFETEST, PHREG, LOGISTIC.

Performance optimization using data cleaning and validation on clinical trial data.

Expertise in SAS/Base, SAS/Graph, SAS/Macro, SAS/ODS, SAS/SQL, SAS/STAT, SAS/CONNECT and SAS/ACCESS on WINDOWS and UNIX platforms.

Supported multiple clinical trials in Oncology, Pain, Virology, and Cardiovascular.

Ability to work on multiple projects simultaneously and meet the deadlines as and when required.

Possess outstanding analytical and problem solving skills.

Skills:

SAS Tools: SAS/Base, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS

Environment: Windows, UNIX

Office Tools: MS Word, MS PowerPoint, MS Excel

Databases: Oracle, ClinTrial, MS Access

Professional Experience:

ICON, PA

Jun ’14 – Present

Role: Senior Statistical Programmer

Responsibilities:

Support SAS programming activities for multiple clinical trials for Phases II-III and ISS.

Review study protocols, CRFs, SAPs and output specifications

Participate in the SAS programming activities for production and validation of analysis and reporting of multiple clinical trials

Responsible for providing SAS programming and analysis support for ISS and CRT packages for submissions

Create and review define documents, SAS transport files and patient profiles

Participate in the efforts to develop standard templates for ADaM datasets for assigned projects

Create and validate CDISC-compliant SDTM and ADaM datasets

Create statistical reports for continuous, categorical and survival efficacy endpoints

Merge data from multiple trials for generating integrated tables/graphs for ISS by resolving merging issues.

Generate TLGs in the domains of demographics, baseline characteristics, patient disposition, previous and current therapies, adverse events, laboratories, vital signs, and efficacy

CSL Behring, PA

Jan’12 – Jun’14

Role: Biostatistical Programmer

Responsibilities:

Performed data conversions from legacy data to SDTM Standards and from SDTM data to ADaM standards

Independently worked with the biostatistics and clinical teams for the analyses to support ad-hoc requests

Routinely worked on analyzing Clinical Trial Data and generating final TLGs for clinical study report (CSR)

Created standard SAS macros to produce various reports such as annotated Kaplan-Meier plots

Created edit check programs to find data discrepancies in datasets and maintain issue and resolution logs

Extensively worked with domains including but not limited to DM, AE, LB, VS, CM, EX, MH

Worked on TLGs for efficacy endpoints, adverse events, lab shift, vital signs, prior and concomitant medications, subject disposition, etc.

Worked on the analysis and reporting of Phase-I Pharmacokinetics (PK) and Pharmacodynamics (PD) studies in quick turnaround scenarios

Acucela, WA

Jan’09 – Dec’11

Role: Statistical Programmer

Responsibilities:

Provided SAS programming support for the analysis and reporting of safety and efficacy for multiple clinical studies for Phases II-IV

Participated in the SAS programming activities for ISS and ISE

Worked on datasets in domains of treatment, baseline and demographics characteristics, individual and derived endpoints, adverse events, laboratory, vital signs, etc.

Worked on Ad-hoc programming requests from clinical department

Extensively used SAS ODS to create reports in RTF and PDF formats

Created common utility macros that are useful across multiple studies

Extensively used SQL language queries and joins in SAS programs creating datasets and TLGs

Worked on Kaplan-Meier macro to generate KM plots as per the requirements and time to event data to generate required results to the comparator drug and the control drug

Authored programming requirement specification documents and followed good programming practices by creating detailed documentation of programs in program headers

Worked on macros to create safety reports like lab shift tables and efficacy reports like change from baseline statistics for primary and key secondary endpoints

Education:

Master of Statistics, Syracuse University, Syracuse NY

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