*** JOB DESCRIPTION ***
KEY TASKS & RESPONSIBILITIES
➢ Perform the role of Lead Statistical Programmer for assigned projects
➢ Continually seek ways and means to provide more efficient and effective programming practices
➢ Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data
Analysis (CDA configuration) module in elluminate.
➢ Develop SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration
➢ Develop specifications for Analysis Data Model (ADaM) datasets
➢ Develop SAS programming for ADaM datasets
➢ Responsible for developing and maintaining programming and validation specifications for TLGs as
per requirements provided by the Biostatistician
➢ Create and maintain SAS programs to produce outputs to support the analysis and reporting of
clinical trials
➢ Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
➢ Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the
statistical models used for programming
➢ Develop re-usable utility macros in order to build a macro library to support programming tables,
listing and graphs for phase 1-4 clinical trial reporting
➢ Collaborate with the project team to ensure the deliverables are completed on time with high quality
➢ Create submission-ready standard data presentations and data sets using standard coding and
following standard industry processes including SDLC
➢ Maintain all project documentation as required by SOP and Processes
➢ Mentor statistical programmers
➢ Ensure compliance with eClinical Solutions and industry quality standards, guidelines and
procedures
➢ Other duties as assigned
CANDIDATE’S PROFILE
Education & Experience:
➢ Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in healthrelated field, computer science or equivalent preferred
➢ Excellent knowledge of English
Professional Skills
➢ Experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred.
➢ Strong experience in preparations for NDA filings
➢ Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
➢ Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
➢ Knowledge of CDISC® related data models like SDTM, and ADAM.
➢ Experience of working on multiple clinical protocols at the same time.
➢ Excellent verbal and written communication skills
➢ Detail oriented, ability to multitask with strong prioritization, planning and organization skills
➢ Excellent team player
Technical Skills
➢ Experience of extracting, manipulating, merging, summarizing, analyzing, and presenting data using
SAS procedures
➢ Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various
SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a
must.
➢ Experience with reporting environments and reporting tools related to SAS programming in
pharmaceutical industry; proc report, proc summary and proc tabulate.
➢ Strong experience in SAS programming in various phases of clinical trial.
➢ Experience in pooled data analysis and programming.
➢ Strong experience in efficacy reporting with regards to development of analysis sets and treating
missing values.
➢ Experience in working with relational databases and performance tuning of SAS programming
➢ Experience with writing batch scripts and/or shell scripts is a plus