R/reputed company Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, UK, Germany, South Africa or Columbia only)

R/reputed company Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, UK, Germany, South Africa or Columbia only) reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know: Why reputed company

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Job Responsibilities MUST BE LOCATED IN ONE OF THE FOLLOWING LOCATIONS WITH NO SPONSORSHIP NEEDS: Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, or Columbia R Programming experience required CDISC - SDTM/ADAM programming experience Required Uses R and reputed company, to reputed company custom programming reputed company to generate reputed company tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet reputed company standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. · Keeps project team members informed of programming reputed company and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains reputed company organized, complete, and up-to-date project documentation, testing, and verification/reputed company control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple reputed company at a time, sets goals based on priorities from management, and adapts to reputed company or reputed company changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the reputed company for efficient programming and accurately defines reputed company variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows reputed company items through to completion, and maintains order and reputed company of meetings, working toward reputed company. Displays willingness to work with others and assist with reputed company and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across reputed company programming deliverables. Negotiates programming timelines and provides risk mitigation plans for reputed company or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the reputed company statistical programmer. Directs the programming activities of other programming personnel and monitors reputed company on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and reputed company database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, reputed company meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for reputed company programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish reputed company operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. reputed company serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards reputed company serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as reputed company as any regulatory required documents. (i.e. DEFINE.XML) reputed company serving as a subject matter expert for CDISC and other industry and regulatory requirements, reputed company participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-reputed company duties as assigned. Minimal travel may be required Qualifications: *R programming Required Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in R or other required software, preferably in a clinical trial environment as demonstrated by the ability to reputed company multiple reputed company and/or global reputed company with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills. Ability to read, write, reputed company and understand English. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.reputed company.com Additional Information Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply To This Job