Principal Statistical Programmer

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.The Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials.ResponsibilitiesExceed expectations and responsibilities of a Senior Statistical ProgrammerUnderstand and implement CDISC and other regulatory standardsFollow internal SAS programming conventionsServe as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsorCoordinate and ensure the accuracy and completeness of activities for assigned support programmersCreate and maintain project timelinesDesign, develop, document and validate tools and macros to improve quality and efficiency of processesPrepare and review programming specifications for SDTM, ADaM and other derived datasetsApply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:Analysis datasets (SDTM, ADaM, other derived datasets)Tables, listings and figuresxml/Reviewer’s GuideIntegrated summariesPerform ad hoc analyses of current and legacy databasesReview and provide input on case report form designServe as a subject matter expertTrain and mentor others in task executionProactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needsDevelop department training materials and deliver trainings to the teamDrive/facilitate/actively engage in department initiativesWork effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputsStandard Operating Procedures (SOPs)Strong understanding of departmental and company procedures; ability to guide others on proceduresParticipate in the development and revision of department SOPsBusiness DevelopmentSupport the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.Additional ResponsibilitiesAssist in the preparation and review of monthly financial reportingPromote visibility outside of the functional area and effectively interact cross-functionally and in industryParticipate in candidate interviewsPerform other duties as requested by managementQualifications:The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degreeMinimum of 6 years direct SAS programming experience in pharmaceutical development or CRO environmentGood knowledge of medical terminology and conduct and analysis of clinical trialsKnowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.)Excellent oral and written communication skills, organizational skills, and attention to detail are requiredAt Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.Equal Employment OpportunityIt is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.