Salary: Market related
Reference: JOB-5706
Contact: Linda Aronova – laronova@penfieldsearch.com
No 3rd party applicants
Responsibilities:
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Independently develop/validate programs that generate SDTM and analysis datasets based on ADaM specifications.
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Prepare/QC ADaM datasets documentation: Define.xml, Reviewer’s Guide and analysis metadata report.
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Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP)
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Perform quality control on final reports.
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Provide QC and validation reports.
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Support development of technical programming specifications for ADaM standards
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Communicate with programming and statistics leads, data managers and other team members.
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Provide project progress updates of programming activities.
Requirements:
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BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences
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10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
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Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat
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Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus.
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Experience with all clinical phases I, II, III and IV of trials is desirable.
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Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
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Strong problem-solving skills
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Good organizational and time management skills
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Excellent communication skills and capability of communicating technical concepts.
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Excellent organizational skills with demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.