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.