Senior Statistician

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:

• Review clinical study plans, including protocols for randomized controlled trials.
• Utilize advanced planning tools and methodologies to ensure robust study designs that meet regulatory and scientific standards.
• Define randomization strategies and statistical endpoints.

Data Analysis and Interpretation: 

• Perform statistical analyses on clinical trial data from datasets exceeding 1,000 patients.
• Review and interpret clinical study results to evaluate hypotheses and guide decision-making.
• Ensure statistical integrity and compliance with regulatory requirements.

Scientific Communication:

• Write and review the statistical components of scientific manuscripts, abstracts, and clinical study reports.
• Collaborate with cross-functional teams to effectively communicate findings to internal and external stakeholders.

Advanced Statistical Modeling:

• Develop and apply predictive statistical models using training datasets to forecast outcomes and trends.
• Employ advanced techniques such as machine learning and multivariate analysis to enhance data interpretation and predictive accuracy.

Regulatory and Compliance:

• Ensure all statistical methods and analyses comply with relevant guidelines (e.g., FDA, EMA, ISO).
• Contribute to the preparation of regulatory submissions and responses.

Team Collaboration:

• Provide statistical guidance to clinical and regulatory teams.

QUALIFICATIONS:

Education:

• Master’s or PhD in Statistics, Biostatistics, or a related field.

Experience:

• Minimum of 7–10 years in clinical trial design and analysis, preferably in the medical device or pharmaceutical industry.
• Proven track record of designing and analyzing randomized controlled trials.

Technical Skills: 

• Proficiency in statistical programming languages such as SAS, R, or Python.
• Experience with advanced statistical methods, including predictive modeling and machine learning techniques.
• Familiarity with handling large datasets and clinical data management systems.

Soft Skills: 

• Native English speaker or highly proficient/fluent in speaking English
• Strong problem-solving skills and attention to detail.
• Excellent communication and writing skills, with the ability to explain complex statistical concepts to non-statisticians.
• Collaborative mindset with experience working in cross-functional teams.

PREFERRED QUALIFICATIONS:

• Experience in regulatory submissions for medical devices.
• Knowledge of Good Clinical Practice (GCP) and ISO standards for clinical trials.
• Familiarity with clinical trial design software and advanced planning tools.