Position Name: Biostatistician

Job Description

Develop SAP (Statistical Analysis Plan) and table shell
Developed and validated SDTM and ADaM datasets under CDISC standard, including DM,
AE, LB, VS, SV, ADSL, ADAE, ADQS, ADLB, etc.”  
Generated and reviewed ADaM spec and made updates based on SAP and TFL shell
requirements.
Worked with an in-house group to generate TFLs, including time to events, adverse events,
lab-shift, change from baseline, demographics, and baseline characteristics, etc. 
Working DDL (Domain Data listings) and AD HOC requirement to develop macro programs
to check data consistency and detailed changes between different raw datasets transfers and
report to physician and data management.  
Utilized PROC LIFETEST to perform survival analysis and overall survival results and
implemented PROC TEMPLATE/SGRENDER to generate customized Kaplan-Meier plots
with median days of survival and p-value from log-rank.
Led a study safety research project from individual completed and ongoing studies, and
responsible for Both tables and listings for publication research to study the relationship
between G-CSF and platelets. 
Create Macros for various instances for automating listings and tables of clinical data for
analysis.  
Finished the ad hoc request from the statistician for some exploratory analysis including
variance analysis, subgroup analysis. 
Supported ISS ADaM data from individual studies and added variables for analysis including
SMQ, special-interest adverse events, and occurrence flags for DSUR safety analysis. 
Reviewed annotated CRFs, SDTM and ADaM mapping spec, and other study related
documents.
Attended study specific meetings with internal and client teams.  
Attended weekly meetings with CRO to discuss the peer-review/validation results of
deliverables.

Requirements

Master’s degree in Statistics, Biostatistics, and Mathematics. Excellent CSISC knowledge
and SAS programming skills in SDTM and ADaM.

Solid SAS Coding Skill: Proven
skills in creating and validating datasets, Macros, TFL generation and data mapping.
Proficient in statistical analysis and modeling including PROC FREQ, PROC MEANS,
PROC MIXED, PROC GLM/PHREG

Send resumes to: jack.zhang@jndataresolution.com