We are seeking an experienced and strategic Senior Manager of Biostatistics to help grow the team at our exciting Rare Disease biotech client. The successful candidate will be responsible for overseeing statistical activities related to the design, analysis, and interpretation of clinical and preclinical data. This role is crucial in advancing their pipeline of rare disease therapies and ensuring the highest standards of statistical rigor and scientific integrity.
Responsibilities:
- Manage and support the biostatistics team, providing mentorship and development opportunities.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to design and execute clinical trials and research studies.
- Develop and implement statistical analysis plans, ensuring robust and reproducible results.
- Prepare statistical sections of clinical study reports, regulatory submissions, and publications.
- Provide statistical consultation to support decision-making across the company.
- Ensure compliance with regulatory guidelines and industry standards for statistical practices.
- Stay current with advancements in biostatistics and rare disease research, integrating new methodologies as appropriate.
Qualifications:
- PhD or equivalent in Biostatistics, Statistics, or a related field.
- A minimum of 7 years of experience in biostatistics within the biotechnology or pharmaceutical industry, with a focus on rare diseases preferred.
- Experience in leading and managing a team of biostatisticians.
- Expertise in the design, analysis, and interpretation of clinical trials and observational studies.
- Proficiency in statistical software such as SAS, R, or equivalent.
- Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA) for clinical trials.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams.
- Proven track record of scientific publications and presentations.
