Biostatistician
About us:
Data Science UA is a service company with strong data science and AI expertise. Our journey began in 2016 with the organization of the first Data Science UA conference, setting the foundation for our growth. Over the past 7 years, we have diligently fostered the largest Data Science Community in Eastern Europe, boasting a network of over 30,000 AI top engineers.
About the company:
The company 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, the company enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, the company clients realize efficiencies in cost and time, while comprehensive solutions unify the entire development process. The company 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.
About the role:
We are looking for a Biostatistician, who will design, plan, and execute biostatistical components of clinical studies. Also, you will contribute to clinical study protocols and reports through statistical analysis, input, and review.
Requirements:
– Bachelor’s or master’s degree or international equivalent in statistics, applied statistics or biostatistics.
– Bachelor’s degree or international equivalent and 2 – 4 years of relevant work experience.
– Master’s degree or international equivalent and 1 – 3 years of relevant work experience.
– Strong knowledge of ICH GCP guidelines.
– Knowledge of moderately complex statistical methods that apply to clinical trials.
– 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.
– Work is typically performed in an office environment, using basic muscular movements, involving only the handling of light materials, tools, or equipment in easy work positions, and with no special speed requirements or long stretches of exertion.
Responsibilities:
– Provides input into and reviews statistical deliverables.
– Coordinates the development and review of statistical analysis plans, table shells, table specifications, table listings, and figures production, datasets, and statistical analysis.
– Develops statistical analysis plans and reporting specifications for clinical studies.
– Effectively collaborates with other stakeholders (project management, data management, statistical programming, and medical writing functional areas).
– Provides statistical support through protocol development, sample size calculation and justification and case report form (CRF) review.
– Applies knowledge of statistical methodology to ensure proper implementation of clinical studies.
– Analyzes and interprets clinical trial results using sound statistical methodology.
– 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.
– Designs all data presentations including summary tables, graphs, and subject listings.
– Performs case report form (CRF) review.
– Trains and mentors new or junior statisticians on statistical methods.
– Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
– Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
– Exercises judgment within defined procedures and practices to determine appropriate action.
– Builds productive internal/external working relationships.
– Receives minimal guidance on day-today work and moderate guidance on new projects or assignments.
The company offers:
– Benefit package.
– Opportunity to collaborate with a dynamic, forward-thinking team.
– Continuous learning opportunities to remain at the forefront of industry trends & advancement.
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