We have a current opportunity for a Sr Manager Biostatistics on a permanent basis. This position can be fully remote with occasional travel. For further information about this position please apply.
Job Title: Senior Manager, Biostatistics
Job Type: Full-Time
Job Summary: We are seeking an experienced and highly motivated Senior Manager of Biostatistics to join our dynamic team. The successful candidate will lead a team of biostatisticians and provide strategic direction for biostatistical activities across multiple projects. This role requires 5 years minimum of managerial experience, excellent communication skills, and a deep understanding of biostatistics in the context of clinical trials and regulatory submissions.
Key Responsibilities:
- Lead and manage a team of biostatisticians, providing mentorship, guidance, and performance evaluations.
- Develop and implement biostatistical strategies for clinical trials, ensuring compliance with regulatory requirements.
- Collaborate with cross-functional teams, including clinical development, data management, and regulatory affairs, to ensure the successful design, execution, and reporting of clinical studies.
- Oversee the development of statistical analysis plans, study protocols, and clinical study reports.
- Ensure the accuracy and integrity of biostatistical analyses and data interpretation.
- Represent the biostatistics function in meetings with regulatory agencies and other external stakeholders.
- Stay current with industry trends, regulatory guidelines, and best practices in biostatistics and clinical research.
- Contribute to the development and implementation of departmental policies and procedures.
Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
- Minimum of 10 years of experience in biostatistics, with at least 5 years in a managerial role.
- Proven experience in the design and analysis of clinical trials.
- Hands on experience in data science applied to clinical study data, including real world data (RWD).
- Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, 510k).
- Proficiency in statistical software (e.g., SAS, R).
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, collaborative environment.
- Strong problem-solving and decision-making abilities.
Preferred Qualifications:
- Experience in working within medical device industry
- Experience with regulatory submissions and interactions with regulatory agencies (FDA, 510k)
- Knowledge of data management and clinical data standards (e.g., CDISC).
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Professional development opportunities.
- Flexible work arrangements.
