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.
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- 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.