Exciting opportunity with a dynamic and innovative biopharmaceutical company dedicated to advancing therapies for patients with rare diseases. With a commitment to improving lives drives our research and development efforts, and we are seeking a talented Senior Manager, Biostatistics, to join their growing team.
Role Overview: As the Senior Manager, Biostatistics, you will play a crucial role in our clinical development programs, providing statistical expertise and leadership. You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and data management, to ensure the successful design, analysis, and interpretation of clinical trials.
Key Responsibilities:
- Lead the statistical planning and analysis for clinical trials, including the development of statistical analysis plans and protocols.
- Collaborate with clinical and regulatory teams to ensure the integrity and accuracy of clinical data.
- Provide statistical input and guidance for study design, sample size calculations, and data monitoring.
- Oversee and mentor a team of biostatisticians and statistical programmers.
- Ensure compliance with regulatory guidelines and standards in statistical reporting.
- Communicate statistical findings and insights to internal and external stakeholders, including regulatory agencies.
Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
- Minimum of 5 years of experience in biostatistics within the pharmaceutical or biotechnology industry.
- Strong knowledge of statistical methods and their application to clinical trials.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Proficiency in statistical software such as SAS or R.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
- Strong problem-solving skills and attention to detail.
