*** JOB DESCRIPTION ***
KEY TASKS & RESPONSIBILITIES
• Determine resourcing needs per project load, deadline requirements and resource utilization.
• Create or review and approve programming plans at study and project level.
• Provide input on key study-related documents produced by other functions (e.g. CRFs, Data
Management Plans, SAPs, etc.)
• 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.
• Assist Biostatisticians by suggesting algorithms to address novel analysisrequests.
• 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.
• Develop re-usable utility macros to build a macro library to support programming tables, listing and
graphs for all phases of clinical trial reporting.
• Create submission ready SDTM and ADaM datasets following standard industry processes,
• Performs peer review of all SAS Programmers deliverables,
• Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex,
technical solutions for projects or business needs,
• Collaborate with the project team and other Professional Services Managers to ensure the
deliverables are completed on time with high quality.
• Develops and maintains good working relationships with internal cross functional teams and
Clients.
• Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in
the training of Standard Operating Procedures and Work Instructions.
• Maintain all project documentation as required by SOP and Processes
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and
procedures.
• May serve as Lead Statistical Programmer on projects when needed.
• Other duties as assigned.
• Bachelor of Science / Master of Science preferably in Statistics, health-related field, computer
science or equivalent.
• Pharmaceutical/Biotechnology industry or equivalent IT consulting role.
Professional Skills
• 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 analysissets and treating
missing values.
• Experience in working with relational databases and performance tuning of SAS programming.