Seeking a Manager of Statistics that will be responsible for most aspects of data management activities in support of assigned clinical studies. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. The Manager of Statistics also ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed.
location: Princeton, New Jersey
job type: Permanent
salary: $170,000 - 190,000 per year
work hours: 9 to 5
- Provide core statistical oversight, leadership and support for all clinical & research studies with APOC
- Oversee the appropriate allocation of statistical group resources to individual studies and projects
- Ensure the timely completion of all statistical deliverables to meet business needs.
- Responsible for providing statistical expertise at both the study and project levels in the areas of: experimental, protocol, and case report form design, database structures, and analysis plans; and collaborate with writers to determine content of and to complete joint reports, including the review of such reports to ensure accuracy and clarity.
- Ensure close communication and working relationship cross functional groups such as R&D, regulatory, quality, PMO and other necessary functional teams
- Ensure compliance with GCP, quality and regulatory compliance and other APOC site specific compliances
- Interpret federal regulations for statistical analysis and act as subject matter experts for project teams.
- When required, participate in interactions with FDA reviewers and/or compliance personnel for statistical support activities in all areas of APOC products
- Responsible for the review and approval of protocols, regulatory submissions and labeling that includes data processed by the statistics group
- Responsible for interviewing, hiring and training of new statisticians
- Provide supervision and mentorship to staff for their development and performance reviews
- Responsible for managing statistical group budget
- Support and align with corporate initiatives such as training courses and corporate statistical standards documents.
- Provide updates to Senior management team as required
- Facilitate issue resolution across these functional areas as it relates to statistical analyses.
- Be proactive to provide risk mitigation strategies
- Other miscellaneous duties as needed
- Master's degree is required in Statistics, strong preference for PhD in Statistics;
- A minimum of 12 years of relevant experience in Clinical Research;
- A minimum of 5 years demonstrated people leadership experience and experience with budgetary responsibility;
- IVD experience is preferred.
skills: Biostatistical Analysis
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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