Statistician (Alajuela, Costa Rica)

Responsibilities

• Study Design and Planning:
• Provide expert statistical input and guidance in the development of clinical study protocols, including sample size calculation, randomization, hybrid study designs, real-world evidence studies, and statistical analysis plans
• Collaborate with cross-functional teams to define study objectives, endpoints, and statistical considerations, ensuring alignment with regulatory requirements and business goals
• Statistical Analysis:
• Leverage statistical software tools such as SAS and R to generate accurate and reliable results, and learn new languages/tools/techniques as needed
• Perform advanced statistical modeling and study simulation techniques to support decision-making and optimize study designs
• Data Management and Quality:
• Conduct thorough data review and quality control checks to identify any discrepancies or outliers, ensuring data integrity and reliability
• Collaborate with Data Science and Statistical Programmers to guide the cleaning of large real-world datasets
• Results Interpretation and Reporting:
• Prepare and present statistical analysis results, study findings, and statistical methodologies to internal stakeholders, project teams, and regulatory authorities
• Contribute to the development of Clinical Study Reports (CSRs), statistical sections of regulatory submissions, and other relevant documents
• Statistical Expertise and Guidance:
• Stay abreast of latest statistical methodologies, industry standards, and regulatory guidelines relevant to medical device clinical studies
• Provide statistical expertise to guide internal teams, including mentoring junior statisticians and cross-functional colleagues on statistical concepts and methods
• Location : Hybrid (Costa Rica - needs to be able to work 9-5 EST)
• Education:
• At least a bachelor's degree in a relevant field (e.g., biostatistics, statistics, mathematics, physics, data science). A relevant graduate degree is strongly preferred.

Requirements

• Experience as a clinical statistician in an academic or industry setting
• Proficiency in SAS and R
• Experience in the analysis and reporting of clinical study data, including the preparation of CSRs and statistical sections of regulatory submissions
• Familiarity with clinical study simulation to predict clinical outcomes or inform clinical study design
• Experience independently cleaning and analyzing large real-world datasets, e.g., building patient cohorts and evaluating large registry databases, and using observational research methods (preferred)
• Experience with CDISC standards and working with large clinical trial datasets (preferred)
• Experience in version control such as Git (preferred)
• Experience with Propensity Score Matching techniques (preferred)
• Language
• Advance English
• Knowledge:
• Comprehensive knowledge of statistical methodologies, study design, and clinical trial regulations/guidelines (e.g., FDA, ISO)
• Competences:
• Excellent communication skills, with the ability to clearly and concisely communicate statistical concepts to non-statistical stakeholders
• Strong problem-solving skills, curiosity to investigate and learn more, drive to innovate, and the ability to work either independently or as part of a team
• Strong communication, time management, and passion/motivation are essential in this position
• Travel Requirements :
• You. Unlimited
• We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
• Inclusion + Belonging - Committed to Welcoming, Celebrating and Thrivin

Benefits

Additional Information

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Founded in 1856, Smith+Nephew is one of the longest-established medical device companies in the world, and has been trusted with the health of millions of individuals worldwide. We are seeking a driven, adaptive, and creative Statistician to support Smith+Nephew's Global Biostatistics & Data Science group under Global Clinical and Medical Affairs. The Biostatistician will be responsible for innovative statistical methodologies and generating trusted results to support a variety of clinical studies across our Advanced Wound Management, Orthopedics, and Sports Medicine & ENT global portfolios. This will include working cross-functionally to develop clinical study designs and protocols, writing Statistical Analysis Plans, hypothesis testing, and creating TFL's with the support of Statistical Programmers. The successful candidate will be first and foremost a lifelong learner. They will have a strong foundation in clinical biostatistics, and a true passion for innovation. If this sounds like you, then we encourage you to apply!

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