Senior Biostatistician

We are seeking a highly skilled and experienced Senior Biostatistician to join our team. This role involves providing advanced statistical expertise and leadership for clinical trials conducted by our clients in the pharmaceutical, biotechnology, and medical device industries. The Senior Biostatistician will be responsible for ensuring statistical integrity in trial design, data analysis, and reporting while maintaining close collaboration with cross-functional teams. Your contributions will play a vital role in delivering high-quality results and advancing healthcare solutions.

Key Responsibilities:

Study Design and Statistical Planning:

• Collaborate with clinical and project teams to design clinical trials, ensuring robust statistical methodologies and appropriate sample size calculations.
• Develop and review statistical sections of study protocols and Statistical Analysis Plans (SAPs), detailing statistical techniques, data handling, and endpoints.

Data Analysis and Reporting:

• Perform and oversee complex statistical analyses, including hypothesis testing, survival analysis, and mixed models.
• Generate and review statistical outputs (tables, figures, and listings) for clinical study reports (CSRs) and regulatory submissions.
• Ensure timely delivery of high-quality statistical analyses in compliance with regulatory standards and study requirements.

Regulatory Compliance:

• Ensure all statistical analyses are compliant with ICH, FDA, EMA, and other relevant regulatory guidelines.
• Prepare documentation for regulatory submissions and address agency queries related to statistical methodologies.

Cross-Functional Collaboration:

• Work closely with clinical, programming, data management, and project management teams to ensure alignment on statistical methodologies and timelines.
• Serve as the primary statistical point of contact for internal teams and external clients, providing clear updates and resolving issues proactively.

Quality Assurance:

• Implement and oversee quality control measures, performing validation of datasets and statistical outputs to ensure data integrity and accuracy.
• Address critical statistical issues by implementing corrective actions and ensuring adherence to best practices in data handling.

Mentorship and Leadership:

• Mentor and guide junior statisticians and team members, fostering a collaborative and learning-focused environment.
• Provide training on statistical techniques and regulatory standards to enhance team capabilities.

Qualifications requirements:

Education:

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

Experience:

• Minimum of 5 years of experience in biostatistics within a CRO, pharmaceutical, or biotechnology environment.
• Strong experience in clinical trials, preferably across multiple therapeutic areas.
• Solid understanding of FDA, EMA, and ICH guidelines, as well as regulatory submission processes.

Technical Skills:

• Proficiency in statistical programming languages, particularly SAS (preferred) and/or R.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Knowledge of survival analysis, mixed models, non-linear models, and other advanced statistical techniques.

Other Skills:

• Excellent communication skills with the ability to explain complex statistical concepts to non-statisticians.
• Strong problem-solving abilities and attention to detail.
• Ability to manage multiple projects simultaneously while ensuring high standards of data quality and adherence to timelines.

Preferred Qualifications:

• Expertise in programming languages such as Python or JavaScript will be beneficial
• Experience in submission-related interactions with regulatory authorities would be a significant advantage.