We are seeking an experienced and visionary Senior Manager/AD of Biostatistics to lead in our client biostatistics team. The successful candidate will be responsible for providing strategic and operational leadership in the design, analysis, and interpretation of clinical and preclinical data. This role is critical to advancing our pipeline of rare disease therapies and ensuring the highest standards of statistical rigor and scientific integrity.
Responsibilities:
- Lead and manage 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.
- Oversee the preparation of statistical sections of clinical study reports, regulatory submissions, and publications.
- Provide expert 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 8 years of experience in biostatistics within the biotechnology or pharmaceutical industry, with a focus on rare diseases preferred.
- Demonstrated 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.
