AMVETS Jobs

• Preferably at least 10 years of experience in statistical programming or biostatistics activities in the Pharmaceutical/Biotechnology industry in clinical development or equivalent experience • Experience with statistical programming in Oncology • Strong experience in global regulatory submission Responsibilities: • Serve as the biostatistical programming expert and leader; Interact with clinical project and product strategy teams and communicate plans and strategy to subordinates. • Provide programming support for the development and QC of analysis datasets and outputs for individual study as well as integrated analyses. • Ensure high quality, traceability, reproducibility, and timeliness of statistical programming deliverables to meet expectations and regulatory requirements. • Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and electronic data submission strategies. • Deliver exemplary performance and solve complex technical problems to inspire other programmers. • Ensure an efficient collaboration with programming teams in Global Team (e.g. EU). • Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: • Clinical study reporting, e.g. ICH E3 • Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11 • Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards. • Interact with regulatory authority personnel on clinical trials programming issues and regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables. • Lead the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness. • Mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…). • Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Skills and Education: • Proficient in SAS • Good knowledge of CDISC ADaM and SDTM • Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions • Strong knowledge of relevant regulatory and data submission guidelines • Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding statistical programming processes, management of statistical programmers and customer management • Strong project management skills • Good negotiation and issue resolution skills • Ability to organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills • Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirementsIf your skill set match above required, please forward your resume as a word attachment along with contact number and salary requirements.