Senior Statistician I

We are seeking an experienced and collaborative Senior Statistician to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets.

Key Responsibilities:

• Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables.
• Participate in cross-functional study-related activities and team meetings.
• Perform sample size calculations and author or review statistical analysis plans (SAPs).
• Coordinate with Biostatisticians, Statistical Programmers, and Data Managers to prepare, conduct, and review statistical analyses.
• Ensure the accuracy and integrity of final statistical outputs and deliverables.
• Guide and supervise programmers in developing analysis dataset specifications and programming/validation oftables, listings, and figures (TLFs).
• Validate analysis variables and statistical outputs for consistency and compliance.
• Conductquality control (QC)of data displays and analysis datasets prepared by others.
• Maintain project administration files including protocols, annotated CRFs, SAPs, annotated shells, programming/QC rules, tracking logs, and communications.
• Participate in internal meetings and contribute to Biostatistics and Development Team initiatives.

Primary Skills:

• Statistical Methodology: Advanced statistical techniques, sample size estimation, inferential statistics
• Programming: Proficiency inSASand clinical data analysis tools
• Documentation: SAPs, annotated shells, QC logs, and regulatory documentation
• Collaboration: Cross-functional teamwork with clinical, data, and sponsor teams
• Leadership: Project management and mentoring of junior team members

Secondary Skills:

1. Regulatory Knowledge:
2. Understanding of drug development and submission processes
3. Quality Assurance:
4. QC of datasets and statistical outputs
5. Communication:
6. Clear and effective communication with technical and non-technical stakeholders
7. Project Organization:
8. File management, version control, and audit readiness
9. Software Proficiency:
10. MS Word, Excel, PowerPoint, and project management tools

Preferred Qualifications:

1. Masters degree inStatisticsor related field with6+ yearsof industry experience
2. PhD in Biostatistics or related field with3+ yearsof postgraduate experience
3. Proven ability to lead projects and manage cross-functional teams
4. Strong foundation in statistical methodologies andSAS programming
5. Experience with clinical trial data analysis and regulatory submissions

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.

1. Applies scientific methods to analyse and solve software engineering problems.

2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.

3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.

4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.

5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.