Senior Statistical Programmer - eClinical Solutions

Senior Statistical Programmers will work with clients and provide SAS programming expertise in data extraction from various databases, TLG programming, developing programming and validation specifications. Provide hands-on expertise in programming CDISC SDTM and ADaM datasets to support various analyses and TLG Programming.

KEY TASKS & RESPONSIBILITIES

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 CDSIC standard dataset specifications and follow specifications to create SDTM and ADaM datasets

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

Education/ Language:

Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health related field, computer science or equivalent

Excellent knowledge of English

Professional Skills & Experience

Minimum 5-7 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role

Strong experience in preparations for NDA filings

Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies

Strong Knowledge of CDISC- data models including SDTM, and ADaM

Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)

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 :

Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures

Hands-on experience with CDISC data mapping and standardization programming

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

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