The primary responsibilities of this position will be to lead database or statistical programming activities and provide end to end programming support in planning, specifying, designing, developing, and implementing solutions for the clinical trials in accordance with applicable processes. Provide extensive technical expertise as part of the Database and Statistical Programming (DSP) team to develop, test, maintain, validate, and document programs to meet business needs. Provide support to the development of project-related solutions to the full scope of database and statistical programming tasks.
Leads all the programming activities, including planning, organizing, delegating, coordinating, and managing programming activities, from start to finish by overseeing all development, validation, and production of programs for a set of studies or multiple clientsProvides technical solutions to a wider range of problems with higher level of complexityIndependently determines and develops approach to solutionsAdapts to changing circumstances, policies, work assignments, and/or team membersCreates and maintains complete and up-to-date study documentations in compliance with Pharmapace and regulatory standardsTracks projects against goals and submits status reports to project managementRecommends technical and process solutions that can be used or developed to increase efficiency of project workMay maintain or develop departmental procedures and standardsContributes to the development of department-level standards, tools and templatesContributes to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting proceduresNegotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing / priority constraintsManages projects independentlyMentors junior analysts/programmersMay supervise junior analysts/programmers
EducationBachelors or above degree in statistics/biostatistics, computer sciences, or related fieldsExperienceMinimum 8 years of experience in the pharmaceutical/biotech industry for Bachelors and 6 years for MastersExperience in leading the programming activities for submissionsSkillsExcellent skills in SAS programming for clinical studiesExcellent clinical trial knowledge is preferredWorking knowledge of other software such as S-plus and WinNonlin is preferredExcellent knowledge in industry standards, such as the ICH guidelines, CDISC data standards, 21 CFR Part 11, and FDA guidelines, is requiredExcellent organizational skills, time management, and ability to coordinate workload and meet established timelinesExcellent communication and interpersonal skills to effectively interface with othersAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability