Sas Programmer

*** 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

CANDIDATES PROFILE

Education & Experience:

Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health-related 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 plusRole & responsibilities

Preferred candidate profile