Statistical Programmer 2 in Veranex

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 RequirementsMaster of Science in Mathematics/Statistics/Computer Science/Life Science or M.S. or B.E. SkillsGood communication skills, both written and verbal. Good language skills with an eye for grammar/punctuation. Good time management and planning skills. Good team working characteristics, capable of working in cross-functional teams. Ability to multitask and prioritize work. Paying close attention to detail, timeliness and quality. Significant knowledge of drug development and clinical research. ResponsibilitiesTo maintain a high level of professionalism, performance, productivity and quality. To undergo Regulatory training, ICH GCP and 21 CFR Part 11 training. To read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.). To complete the Project Specific Trainings and maintain appropriate documentation. To perform role of primary and/or validation programmer for all assigned studies. To annotate eCRF using Dataset specifications and create annotated CRF (aCRF). To review CRF annotations. To develop user specific Edit check programs to check the quality of the datasets. To identify and document the data issues through appropriate trackers and report to the Lead Programmer. To develop SAS programs/macros, templates and utilities for data cleaning and reporting if required. To perform Reconciliation of the External data. To develop SDTM and ADaM specifications as per the client requirements. To develop/validate CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications. To create Define.xml, SDRG and ADRG documents. To create Annotated Mock shells if required. To develop/validate tables, listings, and graphs using Mock shells. Responsible for all Statistical Programming activities including Self-Validation checklists. Efficient in both production and QC of analysis datasets, tables, listings and figures. To ensure all programs are compliant with the SOPs and project specific guidelines. To perform First Time Quality Control on reports created. To provide SAS programming support for Data Management. To communicate with the Lead Programmer on the status of daily assigned tasks and study related questions. To support the study documentation on the assigned project in accordance with SOPs to ensure traceability and regulatory compliance. To contribute on process improvement initiatives. To provide advanced technical expertise and work under a minimal supervision to support various programming activities. To ensure clear and proactive communication with the project teams to clarify requirements and specifications, then start the project tasks accordingly. To support junior programmers working on the project and support training requirements for the trainees. Self-learning and development on department specific skill sets. To complete training documentation on timely basis. To support/assist in audit specific requirements for internal/external audits. 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.Apply Now Show more Show less Посадовий рівень Базовий рівень Тип зайнятості Повний робочий день Посадові обов’язки Дослідження, Аналітик і Інформаційні технології Галузі Виробництво медичного обладнання