Biostatistician 2

2 weeks ago

Bengaluru Karnataka, 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.

Level-specific responsibilities
Prepares statistical analysis plans and statistical methodology section of protocol under the guidance of senior level statisticians.
- Assists with the protocol development and review by evaluating protocol for inconsistencies and errors.
- Prepares randomization plan and generates randomization schedule.
- Trains and mentors new or junior statisticians on statistical methods.

Knowledge, skills and abilities
- Strong knowledge of ICH GCP guidelines
- Good knowledge of creation and review of safety and efficacy data analysis
- Sound knowledge of relevant Data Standards

Good knowledge of the SAS computing package
- Good understanding of statistical analysis plan (SAP) and mock shell creation and review
- Good written and oral communication skills including conflict management and the ability to negotiate
- Excellent attention to detail
- Strong analytical skills and ability to prioritize
- Good ability to plan, implement, and monitor the statistical processes for clinical studies
- Ability to solve simple to moderate problems
- Good ability to effectively manage multiple tasks and projects

Minimum experience
Master’s degree or international equivalent and 3-5 years of relevant work experience

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