Sr Statistical Programmer
Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
MINIMUM REQUIREMENTS
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Master of Science in Mathematics/Statistics/Computer Science/Life Science or M.S. or B.E.
SKILLS
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Good communication skills, both written and verbal.
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Good language skills with an eye for grammar/punctuation.
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Good time management and planning skills.
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Good team working characteristics, capable of working in cross-functional teams.
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Ability to multitask and prioritize work.
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Paying close attention to detail, timeliness and quality.
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Significant knowledge of drug development and clinical research.
RESPONSIBILITIES
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To maintain a high level of professionalism, performance, productivity and quality.
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To undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings.
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To read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells etc.) and provide review feedback if any.
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Responsible for initiation of protocol and SAP discussion and actively participate in the discussion, communicate with the Lead Statistician when required.
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Responsible for setting up the study work area in the production server.
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To assist in the development and maintenance of the SAS programs/macros, create templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data.
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To annotate eCRF using Dataset specifications and create annotated CRF (aCRF) or review as required.
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To develop SDTM and ADaM specifications as per the client requirements and complaint to the CDISC standards and to develop programming plan for statistical outputs (datasets, tables, listings, figures, etc.) supporting clinical study reports, regulatory submissions and publications.
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To provide CDISC expertise and ensure adherence to SDTM, ADaM standards.
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To develop SDTM and ADaM specifications as per the client requirements.
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To develop/validate CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications.
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To create Define.xml, SDRG and ADRG documents.
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To create Annotated Mock shells if required.
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To manage programming and resource requirements to meet timelines, alerting Project Manager of potential issues and delays.
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To coordinate and oversee Project activities.
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To contribute to project specific objectives and team deliverables.
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To perform role of primary and/or validation programmer for all assigned studies.
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To independently perform quality control on statistical outputs created internally, to achieve First Time Right outputs.
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To ensure all programs are compliant with the SOPs and project specific guidelines.
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To provide advanced technical expertise and support to the programming team.
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To ensure clear and proactive communication with the project teams to clarify requirements and specifications, then start the project tasks accordingly.
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To mentor junior programmers working on the project and support training requirements for the trainees/team members.
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Self-learning and development on department specific skill sets.
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To complete training documentation on timely basis.
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To support/assist in audit specific requirements for internal/external audits.
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Other duties as assigned by Head of Department.
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
Other details
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- Pay Type Salary
- Employment Indicator Regular