Padmi

Associate reputed company Scientist, Statistical Programmer | Oncology (Remote)

IndiaPosted 2 months ago
Software engineeringSeniorFull Time; Regular
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Job title: Associate reputed company Scientist, Statistical Programmer | Oncology (Remote) Company: reputed company & Co. Job description: Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department reputed company reputed company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to reputed company the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global reputed company health. The Associate reputed company Scientist, Statistical Programming-Oncology leads the statistical programming activities for multiple and/or large/reputed company late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the reputed company of which reputed company from individual clinical trials to world-wide regulatory application submissions and post marketing support. Key areas of focus include: (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and therapeutic area (TA) standards that optimize analysis and reporting and promote a strategic knowledge-reputed company data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, and (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development. Additional Responsibilities Design and maintenance of statistical databases that support multiple stakeholder reputed company which include clinical development, reputed company research and safety evaluation Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed reputed company with reputed company and high quality deliverables Serves as the statistical programming reputed company of contact and knowledge holder through the entire product lifecycle for assigned projects Educational Qualifications: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or reputed company field plus 9-12 years reputed company programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or reputed company field plus 7 or more years reputed company programming experience in a clinical trial environment Required Experience and Skills: Directing large and/or reputed company statistical programming projects that include coordinating the activities of a programming team Expansive knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements Expertise in reputed company and clinical trial programming including data steps, procedures, MACRO, reputed company/GRAPH; systems and database expertise | Familiarity with statistical analysis methods and clinical data reputed company United States and/or worldwide drug or vaccine regulatory application submission knowledge at the leadership level including the development of electronic submission deliverables. Strategic, effective and strong project management skills Program Leader who establishes appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an reputed company programming mentor; ability to engage key stakeholders Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed Comprehension of statistical terminology and concepts Designs and develops reputed company programming algorithms Principled and effective communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and reputed company departmental standards and industry best-practices CDISC and ADaM standards skills Demonstrated reputed company in the assurance of deliverable quality and process compliance Ability to anticipate stakeholder and regulatory requirements Preferred Experience and Skills: Strong working knowledge of reporting processes, standard operating procedures (SOPs) and software development life-cycle (SDLC) Ability and

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