Our client is looking for a Director - Statistical Programming for their Woodcliff Lake, NJ officesThe position serves the critical role for providing direction and oversight to programming team/activities as well as managing liaisons across the company, with external alliances, vendors, and with regulatory agencies.The Position Will Also Be Responsible For Providing input into submission strategies and will support process and infrastructural improvement, resource and cost management for multiple oncology clinical studies/programs. Managing collaborations with external alliances for all programming related activities. Ensuring successful and effective coordination and communications Managing, reviewing and / or executing statistical programming deliverables for planned statistical analysis, related to study monitoring, clinical study reports, data integrations and regulatory query responses, covering multiple compounds and studies Leading global submission activities including cross company projects. Acting as a programming functional and technical expert to support submission strategy planning, regulatory communication Setting and leading key business objectives or projects within the department Leading development and updating company policies/SOPs; Recommending enhancements for improvement Managing & leading development and enhancement towards standardization and process for consistency, efficiency and accuracy Supporting computer infrastructure improvement with data integrity by working with internal resources and external vendors Participates in recruitment activities; Supporting planning and directing work between internal resources and external vendors Managing CROs and contractors with regarding the compliance, deliverable qualities, timelines and budgets Knowledge/Skills/Abilities Required Minimum of a Master degree in Biostatistics (preferred), Statistics, computer science, or related discipline. Bachelor degree with extensive experience might also be considered. At least 12 years relevant experience in statistical programming in the pharmaceutical industry/CRO environment with people and project management experience. Highly experienced in clinical development statistical programming methods and processes in industry setting required. Regulatory submission experiences in the area of Oncology indications. Have lead programming activities involving CDISC SDTM, ADaM, eSub. Experience with CRO oversight. Strong organizational skills with ability to effectively manage multiple studies/projects. Excellent technical writing and verbal communication skills. Associated topics: ad, alumni, analyst, care, cmo, endowment, fundraise, marketplace, policies, regulatory
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