Job Summary:
This role will play a pivotal part in planning, conducting, and analyzing clinical trials, including randomized controlled trials (RCTs), for groundbreaking medical technologies. The ideal candidate will have a deep understanding of advanced statistical methods, expertise in clinical trial design, and the ability to derive meaningful insights from large-scale datasets.
KEY RESPONSIBILITIES:
Involvement in Clinical Study Design:
1. Review clinical study plans, including protocols for randomized controlled trials.
2. Utilize advanced planning tools and methodologies to ensure robust study designs that meet regulatory and scientific standards.
3. Define randomization strategies and statistical endpoints.
Data Analysis and Interpretation:
1. Perform statistical analyses on clinical trial data from datasets exceeding 1,000 patients.
2. Review and interpret clinical study results to evaluate hypotheses and guide decision-making.
3. Ensure statistical integrity and compliance with regulatory requirements.
Scientific Communication:
1. Write and review the statistical components of scientific manuscripts, abstracts, and clinical study reports.
2. Collaborate with cross-functional teams to effectively communicate findings to internal and external stakeholders.
Advanced Statistical Modeling:
1. Develop and apply predictive statistical models using training datasets to forecast outcomes and trends.
2. Employ advanced techniques such as machine learning and multivariate analysis to enhance data interpretation and predictive accuracy.
Regulatory and Compliance:
1. Ensure all statistical methods and analyses comply with relevant guidelines (e.g., FDA, EMA, ISO).
2. Contribute to the preparation of regulatory submissions and responses.
Team Collaboration:
1. Provide statistical guidance to clinical and regulatory teams.
QUALIFICATIONS:
Education:
1. Master’s or PhD in Statistics, Biostatistics, or a related field.
Experience:
1. Minimum of 7–10 years in clinical trial design and analysis, preferably in the medical device or pharmaceutical industry.
2. Proven track record of designing and analyzing randomized controlled trials.
Technical Skills:
1. Proficiency in statistical programming languages such as SAS, R, or Python.
2. Experience with advanced statistical methods, including predictive modeling and machine learning techniques.
3. Familiarity with handling large datasets and clinical data management systems.
Soft Skills:
1. Native English speaker or highly proficient/fluent in speaking English.
2. Strong problem-solving skills and attention to detail.
3. Excellent communication and writing skills, with the ability to explain complex statistical concepts to non-statisticians.
4. Collaborative mindset with experience working in cross-functional teams.
PREFERRED QUALIFICATIONS:
1. Experience in regulatory submissions for medical devices.
2. Knowledge of Good Clinical Practice (GCP) and ISO standards for clinical trials.
3. Familiarity with clinical trial design software and advanced planning tools.
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