Principal Statistical Programmer
Permanent Employee Opening
DUTIES AND RESPONSIBILITIES
•Creation of SAS programs to generate tables/listings/figures from instructions provided by Biostatisticians and submitting the results of clinical trials for investigational medications.
•Generate and define documents, annotated CRFs, and reviewer's guides per CDISC and FDA specifications and guidelines. Demonstrate your experience in the creation of CDISC SDTM and ADaM models by transforming raw data into these standard domains.
•Support data management by generating data listings. Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages.
•Conduct QC/Validation of SAS code and output produced by other Statistical Programmer.
•Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
•Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
•Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
MINIMUM JOB REQUIREMENTS
•BS or MS in Computer Science or Biostatistics.
•Minimum of 6 years of industry experience in Statistical Programming.
•Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
•Experience in the creation of CDISC SDTM and ADaM models by transforming raw data into these standard domains.
•Extensive experience of data integration.
•Must possess the ability to work in a team environment.
•Excellent written, verbal and interpersonal communication skills.
•Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
•Must live a commutable distance.
inVentiv Health Clinical is seeking to fill this position on behalf of a client company. inVentiv Health Clinical, LLC, an inVentiv Health, Inc. company, is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace. inVentiv Health Clinical is a global CRO and leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bio analytical services, and strategic resourcing from a single clinical professional to an entire functional team. With approximately 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value. We offer exciting career paths for clinical research professionals, including permanent and contract opportunities.
Florham Park, NJ
Fri, 23 Jun 2017 13:01:04 PDT