Principal Statistical Programmer . - Boston University

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Principal Statistical Programmer - MedicalAffairsVertex Pharmaceuticals - Greater Boston AreaPosted 13 days agoOther DetailsAbout this jobJob descriptionThe Principal Statistical Programmer works with Clinical Development, Biostatistics, MedicalAffairs, Health Economics and Outcomes Research and with external vendors if applicable tosupport activities in the planning, design, development, implementation, and management of datato fulfill reports and summarize information required in support of ad hoc requests in postmarketing clinical trials, investigations, and assessments of claims databases, including healtheconomics and outcomes research projects, for Vertex Pharmaceuticals products. The PrincipalStatistical Programmer also supports internal and external requests for input into relevantdocumentation and materials, such as manuscripts, conference posters, and presentations.Key Responsibilities:- Provides expert support and direction regarding statistical programming design to ensuretimely, targeted, and accurate reporting and outcomes from assigned projects and ad hocrequests.- Provides timely, accurate, and adequate responses and inputs for internal and externalquestions, medical affairs documentation, and materials.- Develops, manages, and maintains analysis data and reporting deliverables for assigned VertexPharmaceutical products.- Effectively represents the Biometrics department, as assigned, on cross-functional projects orstudy teams, and also helps to on-board new team members, as appropriate, and completesspecial projects as assigned.- Works with biostatisticians, develops or reviews programming specifications for the ad hocrequest.

- Knowledge of statistical concepts, such as p-values, rates and proportions, frequencies,confidence intervals, survival analysis, non-parametric analysis, repeated measures analysis.Capable of implementing these ideas in clear, efficient SAS code for the purpose of data analysisand reporting.- Familiarity with relevant operating systems (e.g., Windows).- Solid understanding of data collection and database concepts including data collectionprocesses in clinical trials.- Proficiency in problem solving, along with debugging skills to resolve issues with otherprogrammers’ or vendors’ code and/or system macro code, is highly desirable.- Experience with pharmaceutical industry data standards, such as CDISC/SDTM and ADaMdata models.- Basic knowledge of FDA/ICH (International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use) guidelines, the softwaredevelopment lifecycle and 21 CRF Part 11 and other FDA regulations.- Additionally, experience working with data from electronic medical records (EMRs), registrydatabases, external insurance claims databases (i3, GE, etc.) for health outcomes research as wellas epidemiology background or experience would be pluses.- Proven SAS statistical programming experience in a pharmaceutical or CRO setting- Supports statistical programming activities for Medical Affairs and health Economics andOutcomes Research- Responsible for accuracy and reliability of results. Builds and monitors quality in every aspectof job activities- Adapts to changing circumstances, policies, work assignments, and/or team members anddevelops strategies that will allow consistency or continuity of subsequent tasks (e.g., multiplestudies or registries)- Contributes strategies that allow multi-tasking or efficient implementation to reduce executiontime to meet deadlines in fast-paced environment- Development and maintenance of tracking systems, folder systems and archival of analysis- Supports tasks based on the importance of the deliverable and awareness of overall timelines inorder to efficiently produce high quality deliverables

- Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue tothe appropriate person (project team member, lead biostatistician, or management); identifies,communicates and overcomes technical and interpersonal obstaclesDesired Skills and ExperienceMinimum Qualifications:- B.S. and 10 years of statistical programming work experience in Biotech,Pharmaceutical or Clinical Research Organizations- M.S. and 8 years of statistical programming work experience in Biotech,Pharmaceutical or Clinical Research Organizations.Preferred Qualifications:- Good interpersonal and negotiation skills, to complete deliverables by working effectively withothers internally and externally; willingness to partner and collaborate with others in team orinter-functional settings.- Good verbal and written communication skills along with effective business presentation skills.- Sound project management skills, to prioritize multiple tasks and goals to ensure the timely, ontarget and within-budget accomplishment of deliverables.- Good judgment and decision-making skills; knows how to make trade-off decisions whilebalancing ethics and effectiveness.- Outstanding attention to detail to ensure accuracy and reliability of results; builds and monitorsquality in every work activity.About this companyFollow companyVertex creates new possibilities in medicine. Our team discovers, develops and commercializesinnovative therapies so people with serious diseases can lead better lives. Vertex scientists andour collaborators are working on new medicines to cure or significantly advance the treatment ofhepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Foundedmore than 20 years ago in Cambridge, Mass., we now have ongoing worldwide researchprograms and sites in the United States, United Kingdom and Canada. Vertex has consistentlybeen recognized as one of the industry's top workplaces by leading publications such as Sciencemagazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and TheScientist. For more information and to view Vertex's press releases, please visit

Vertex is committed to equal employment opportunity and non-discrimination for all employeesand qualified applicants without regard to a person’s race, color, gender, age, religion, nationalorigin, ancestry, disability, veteran status, genetic information, sexual orientation or anycharacteristic protected under applicable law. Vertex will make reasonable accommodations forqualified individuals with known disabilities, in accordance with applicable law.Recent Updates Vertex Pharmaceuticals is hiring: Director, Global Medical Affairs, Canadao Careers at Vertex Pharmaceuticalso See more jobsOther jobs at Vertex Pharmaceuticals Clinical Project ManagerGreater Boston Area Associate Director, Global Health Economics & Greater Boston Area Associate Director, Biostatistics - Phase IVGreater Boston AreaView more jobs at Vertex PharmaceuticalsSimilar jobs Senior Statistical Programmer, BiometricsGreater Boston AreaPosted 6 days ago Statistical Programmer

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