Statistical Programmer 1

6 months ago

Bengaluru, India Veranex, Inc. Full time

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
- 6 months to 2 years of releavant experience
- M.C.A/Master of science in Statistics or Computer science or Life science/BE.
- Good 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 in detail, timeliness, and quality.
- Significant knowledge of drug development and clinical research.

RESPONSIBILITIES
- To maintain a high level of professionalism and learning.
- To undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings.
- To ensure the completion of in-house statistical programming process and department specific SOPs.
- To undergo training on CDISC data standards.
- To read and understand the Study documents (Protocol, eCRF, Dataset specifications, Edit Check Specifications, Raw datasets etc.).
- To annotate eCRF using Dataset specifications and create annotated CRF (eCRF).
- To review CRF annotations and ensure CRF meets the guidelines of the protocol and check for consistency.
- To develop study 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 programs for external data reconciliation, Medical coding listings, Prohibited medication listings, Custom report programming for data management and Ad-hoc reports or data conversion as per data management requirement.
- 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.

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