Job Title :Position: Director, Statistical Programming & Infrastructure(10+years)
Experiance :10+uears years of experience.
Location : Pune or Jaipur
Short Description :Position: Director, Statistical Programming & Infrastructure The Director is accountable for leading a Statistical Programming team to provide strategic, scientific, and statistical programming leadership to the assigned clinical development program(s). This position oversees the statistical programming deliverables of assigned projects to ensure that the assigned clinical development programs meet scientific, regulatory and quality requirements and are aligned with long-term development goals. This position is expected to ensure the team members contribute to required programming deliverables for the assigned projects/studies that are aligned to the organizational goals and building innovative statistical programming tools and applications. Responsibilities include, but are not limited to: Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical programming. Interface with client’s teams to provide expert guidance on scope and delivery timelines. Represent the statistical programming team in client’s meetings to address deliverables and timelines Address resourcing to adequately staff projects as needed. Assist in the review of key study-related documents, e.g. Protocol, SAP, Case Report Form, Data Management Plan, Database Specifications, DMC plans, SDTM and ADaM specifications and other clinical documents. Write, test, and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports. Build, validate and execute, product and study-level macros and utilities. Be a technical resource for programming group to provide advice on complex programming tasks and/or standards. Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents. Build and lead a team of statistical and clinical programmers for supporting client’s deliverables and FSP models. Other duties as assigned Position Requirements & Experience: Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject or equivalent related experience. 10+ years’ clinical research and development programming experience using SAS. 6+ years of management experience. PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines. Expert level SAS programmer with experience in delivering on complex programming assignments and analysis. Expert level knowledge and extensive hands-on experience of CDISC methodologies. Experience leading or working with centralized teams for Statistical Programming. Experience with the drug development process. Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Technical Skills :Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject or equivalent related experience. 10+ years’ clinical research and development programming experience using SAS. 6+ years of management experience. PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines. Expert level SAS programmer with experience in delivering on complex programming assignments and analysis. Expert level knowledge and extensive hands-on experience of CDISC methodologies. Experience leading or working with centralized teams for Statistical Programming. Experience with the drug development process. Comfortable in a fast-paced company environment with minimal