Director Biostatistics

Job Title: Director of Biostatistics

Location: Fully Remote (Company based in Boston, MA)

Company: Leading Autoimmune Diseases Biopharmaceutical Company

About Us:

We are a pioneering biopharmaceutical company dedicated to advancing treatments for autoimmune diseases. Headquartered in Boston, MA, our mission is to improve the lives of patients through innovative science and transformative therapies. As we continue to grow, we are seeking a highly skilled and experienced Director of Biostatistics to join our remote team.

Position Overview:

The Director of Biostatistics will lead the biostatistics function, providing strategic input and oversight to all statistical aspects of clinical development programs. This role is crucial for ensuring the integrity, quality, and timely delivery of biostatistical services and deliverables. The successful candidate will work closely with cross-functional teams to support the design, execution, and analysis of clinical trials, contributing to the advancement of our pipeline of autoimmune disease therapies.

Key Responsibilities:

Leadership and Management:

• Lead, mentor, and develop a team of biostatisticians.
• Provide strategic direction and oversight for all biostatistical activities.
• Collaborate with senior management to align biostatistical strategies with overall company goals.

Clinical Trial Design and Analysis:

• Design, plan, and analyze clinical trials for autoimmune disease therapies.
• Develop statistical analysis plans (SAPs) and ensure their execution.
• Oversee the development and maintenance of biostatistical methodologies and SOPs.

Regulatory and Compliance:

• Ensure compliance with regulatory requirements and guidelines.
• Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications.
• Represent the company in interactions with regulatory agencies.

Collaboration and Communication:

• Work closely with clinical, medical, regulatory, and data management teams.
• Communicate statistical concepts and results to non-statistical audiences.
• Provide statistical input for publications, presentations, and marketing materials.

Innovation and Continuous Improvement:

• Stay abreast of industry trends and advancements in biostatistics.
• Implement innovative statistical methodologies and tools.
• Continuously improve processes and practices to enhance efficiency and quality.

Qualifications:

Education and Experience:

• PhD or MS in Biostatistics, Statistics, or a related field.
• Minimum of 10 years of experience in biostatistics within the biopharmaceutical industry.
• Extensive experience in the design and analysis of clinical trials, preferably in autoimmune diseases.

Technical Skills:

• Proficiency in statistical software (e.g., SAS, R).
• Strong understanding of regulatory guidelines (e.g., FDA, EMA).
• Experience with CDISC standards (SDTM, ADaM).

Leadership and Communication:

• Proven track record of leading and managing a team of biostatisticians.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a cross-functional team environment.

Other:

• Strong problem-solving skills and attention to detail.
• Ability to manage multiple projects and priorities effectively.
• Self-motivated and capable of working independently in a remote setting.