Principal Biostatistician

About This Role:

As a Principal Biostatistician, you will provide project leadership in Biostatistics for specific company products or therapeutic areas. You will play a pivotal role in developing standards across protocols, including protocol development, analysis plans, and file/report specifications. Your expertise will be crucial in reviewing study setup activities, such as randomization, CRFs, and data edits, while serving as the lead biostatistician on multiple projects. With your keen analytical skills, you will perform statistical analyses, interpret results, and prepare clinical study reports, including integrated summaries for submissions. Your role will also involve reviewing analyses performed by other study statisticians to ensure accuracy, consistency, and quality output. Additionally, you will address regulatory issues and collaborate with external development partners. As a Biostats SMT statistician, you will have the opportunity to act as a CDT statistician under supervision, contributing significantly to our mission of advancing healthcare solutions.

What You’ll Do:

• Manage a moderate or large volume of complex tasks with minimal supervision across one or more drug programs.
• Proactively assess and adapt solutions for the Biometrics department, resolving technical issues.
• Make decisions at the study level across various studies, leading and prioritizing tasks globally.
• Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines.
• Monitor needs and determine resources in consultation with line managers.
• Participate in organization-wide initiatives such as quality and standardization efforts.

Who You Are:

You are a detail-oriented and analytical individual who thrives in a collaborative environment. Your problem-solving skills enable you to navigate complex tasks with ease, and your proactive approach allows you to adapt solutions effectively. You possess strong leadership and communication skills that foster productive interactions with diverse teams. Your commitment to excellence drives you to deliver high-quality outputs, and your passion for biostatistics fuels your dedication to advancing healthcare solutions.

Required Skills:

• PhD in Biostatistics/Statistics or equivalent with 0+ years relevant industry experience
• MS in Biostatistics/Statistics or equivalent with 3+ years relevant industry experience.
• Thorough understanding of statistical principles and clinical trial methodology.
• Ability to provide innovative and practicable technical solutions.
• Working knowledge of medical/biological terminology and clinical trial designs.
• Proficiency in writing and presenting information effectively.
• Conversant with SAS programming and detailed knowledge of statistical software.
• Working knowledge of regulatory guidelines and needs for statistical analysis.
• Demonstrated leadership and communication skills.

Preferred Skills:

• Experience in global-scale task management and decision-making.
• Familiarity with organization-wide initiatives such as quality and standardization.
• Ability to interact with KOLs and collaborators across different disciplines.

Job Level: Management