Remote Lead Biostatistician - Clinical Development

Our client, a groundbreaking biopharmaceutical company, is seeking a highly motivated and experienced Remote Lead Biostatistician to join their Clinical Development team. This pivotal role will lead statistical strategy and analysis for clinical trials across all phases of development, ensuring the integrity and accuracy of data used to support regulatory submissions and product approval. The ideal candidate will possess extensive experience in statistical programming, clinical trial design, and regulatory requirements.

As a fully remote position, you will require exceptional communication and collaboration skills to work effectively with global teams, utilizing advanced digital collaboration tools. This is an excellent opportunity to shape the statistical direction of novel therapeutics and contribute to life-changing advancements from your home office.

• Provide statistical leadership and expertise in the design of clinical trials, including sample size determination and development of statistical analysis plans (SAPs).
• Oversee the statistical analysis of clinical trial data, ensuring accuracy, efficiency, and compliance with regulatory standards.
• Develop and validate statistical programs using SAS or R for data analysis and reporting.
• Interpret statistical results and contribute to the preparation of clinical study reports (CSRs), regulatory submissions (e.g., IND, NDA), and publications.
• Collaborate closely with clinical operations, data management, and regulatory affairs teams to ensure seamless execution of clinical programs.
• Mentor and guide junior biostatisticians, fostering their professional development.
• Stay abreast of evolving statistical methodologies, regulatory guidelines, and industry best practices.
• Present statistical findings and recommendations to internal stakeholders, including senior management and clinical teams.
• Ensure adherence to all relevant regulatory requirements (e.g., FDA, EMA) and internal SOPs.
• Contribute to the strategic planning of statistical activities within the R&D organization.

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related quantitative field.
• A minimum of 8 years of experience in biostatistics within the pharmaceutical or biotechnology industry, with at least 3 years in a lead or supervisory role.
• Strong proficiency in SAS and/or R programming for statistical analysis.
• Extensive experience in clinical trial design, statistical analysis, and regulatory submissions.
• In-depth knowledge of ICH guidelines and regulatory requirements for clinical trial statistics.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to clearly present complex statistical information.
• Proven ability to work effectively in a remote, collaborative team environment.
• Experience managing statistical aspects of multiple projects simultaneously.

Our client offers a highly competitive remote salary, comprehensive health, dental, and vision insurance, a generous retirement savings plan with company match, and flexible paid time off. We provide a robust virtual onboarding process and ongoing support for professional development, including access to online training, webinars, and relevant scientific conferences. This fully remote position offers unparalleled flexibility and the opportunity to lead critical statistical efforts from anywhere, working with cutting-edge treatments and a highly collaborative global team.

You will be an integral part of a mission-driven organization focused on innovation and improving patient outcomes.