Principal Statistical Programmer or Manager 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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Excellent communication skills, both written and verbal.
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Excellent language skills with an eye for grammar/punctuation.
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Excellent time management and planning skills.
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Excellent 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 training, ICH GCP and 21 CFR Part 11 training.
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To read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.) and provide feedback if any.
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Responsible for initiating protocol and SAP discussion and actively participated, communicating with the Lead Statistician when required.
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To assist in developing and maintaining the SAS programs/macros, templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data, if any.
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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 per the client requirements and compliant with the CDISC standards and to develop a 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 and ADaM standards.
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To develop SDTM and ADaM specifications as per the client's 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 manage programming and resourcing requirements to meet timelines, alerting the Project Manager of potential issues and delays.
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To contribute to project-specific objectives and team deliverables.
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To perform the primary and/or validation programmer role 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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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, 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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To provide inputs to improve the current processes, achieve efficiency, and enable the processes to align with the Regulatory/Industry requirements.
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To forecast work for the team, provide a vision of the ongoing project objectives/milestones and clarify the upcoming projects.
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Self-learning and development on department-specific skill sets.
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To complete training documentation on a 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.
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