Principal RWD Biostatistician

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🔥 15 hours ago

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Provide statistical input into clinical development plans, concept sheets, and study protocols. • Perform statistical analyses and interpret clinical trial data to support decision making. • Contribute to the preparation of statistical analysis plans (SAPs) and clinical study reports. • Develop and implement statistical and machine learning models to support analysis of clinical study data. • Write code to build and apply analytical models within study analyses, including predictive or exploratory modelling approaches where appropriate. • Apply statistical techniques, machine learning, or Bayesian methods to uncover insights in clinical datasets. • Design and perform hypothesis testing and exploratory analyses to support clinical development questions. • Conduct statistical analyses using R and/or Python, with SAS used where required. • Work primarily within the biostatistics team to deliver high-quality analyses for clinical studies. • Clearly communicate analytical results and statistical concepts to stakeholders within the study team.

🎯 Requirements

• Master’s degree in Statistics, Biostatistics, Mathematics, or a related quantitative discipline. PhD preferred but not required • Strong statistical and mathematical foundation with excellent logical reasoning skills • Industry experience supporting clinical trials is beneficial but not strictly required for candidates with strong quantitative backgrounds • Experience working with clinical or biomedical datasets is advantageous • Familiarity with cloud computing (AWS, Microsoft Azure, GCP (Google Cloud Platform)) and big-data environment (SQL, Spark, Databricks, Snowflake) – nice to have or bonus • Programming experience in R (required); Python is also beneficial. • SAS knowledge is advantageous, particularly for QC and regulatory outputs, but candidates with strong R/Python skills should be able to learn SAS quickly. • Familiarity with statistical modelling techniques, including regression, survival analysis, or Bayesian methods. • Exposure to machine learning approaches is desirable. Basic familiarity with version control systems (e.g., Git) or willingness to learn quickly. • Strong analytical and problem-solving ability. • High attention to detail and commitment to quality. • Ability to work independently and demonstrate initiative. • Strong communication skills and ability to explain statistical findings clearly. • Collaborative mindset and ability to work effectively within a statistical team environment.

🏖️ Benefits

• Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.