Senior Manager, Statistical Analysis and Programming, Oncology (DG)Major Pharmaceutical Firm, Northern NJ Excellent base salary and bonus plus full benefits and other incentives. DescriptionProvide statistical analysis and programming support for oncology clinical studies and implementation strategies, including the following:Work with Statistical Analysis and Programming TA heads to define project operation strategies for Oncology UnitAssume accountability for statistical analyst and programming support, plan and manage both internal and external statistical programming resources including contract programmers and CROs, etc., for multiple compounds in the Oncology UnitProvide statistical programming support for clinical studies, manage and lead the statistical programming efforts for clinical studies and ensure all deliverables are completed with the pre-defined timelines and are of good qualityManage external vendors, CROs and regulatory agencies with regard to dataset and TLG development, electronic reporting and submission requirementsWork closely with and fully contribute to Biostatistics operations and planning to define and implement standards and processesWork with the statisticians as well as other functional areas (such as data management, clinical operations, project management) to continuously improve processes and increase programming efficiencyAssist in managing multiple resources within and across groups to meet project deliverables with regard to statistical analyses and programming requirementsManage day-to-day programming team operations and raise issues and concerns to supervisor as appropriate QualificationsMinimum of a Master degree in computer science, Biostatistics, or related disciplineMinimum 10 years relevant experience in the pharmaceutical industry or CRO environment plus additional relevant people and project management experienceDemonstrated excellence in SAS statistical programming skills across multiple areas of pharmaceutical biostatistics, with specialized expertise in the areas of record level specs development and programmingMust have prior NDA submission experiences and sound knowledge of regulatory reporting requirementsCDISC SDTM and ADaM implementation experience in the oncology area a plusGood communication skills. Strong teamwork ability/commitment and individual initiative, strong organizational skills Please only apply if you meet the qualifications above. Must have a green card or be a US citizen to apply!! Please respond to CLARK DAVIS ASSOCIATES, 20 Waterview Boulevard, Parsippany, NJ, 07054; Phone (973) 257-8825; Fax (973) 257-8824; E-Mail: dgutowski@clarkdavis.com . For a list of over 200 jobs opportunities, visit our web site at www.clarkdavis.com
SR MANAGER, STATISTICAL ANALYSIS AND PROGRAMMING, ONCOLOGY (DG) Job in Job location not provided