Director Biostatistics Jobs Vacancy in Chiltern
Chiltern urgently required following position for Director Biostatistics. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Director Biostatistics Jobs Vacancy in Chiltern Jobs Details:
Senior Director, Biostatistics
King of Prussia, PA or Home-Based in the USA
Chiltern is seeking a Senior Director, Biostatistics to join our growing team. In this role, the selected candidate will participate in a variety of duties related to supervision of Biostatistics staff as well as overall leadership of the department. Ensure departmental goals and deliverables are met. Plan, analyze and summarize the results of individual clinical studies or groups of studies (integrated summaries) and coordinate the development and review of regulatory submissions (e.g., NDAs). Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines. Manage and/or mentor junior level biostatistics staff.
- Selection, training, development, and performance management for a team of Biostatisticians as well as line managers and Level 1 and 2 Directors
- Efficiently and effectively coordinate statistical activities for multiple projects simultaneously
- Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, including global and cross-region initiatives
- Interact with project team, as well as key internal and external stakeholders, to influence the definition of project priorities and communicate such activities and associated timelines to departmental management
- Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel
- Define achievable goals and tasks as related to a departmental objective or initiative. Identify areas for improvement (e.g. SOPs, processes etc.)
- Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to the Department VP. Actively monitor project budgets and help staff identify resource or scope of work changes
- Represent department and company in multi-disciplinary settings and meetings, including (but not limited to): project team meetings; client meetings/presentations; bid defense meetings; marketing and new business ventures; contributing to bids & proposals submissions.
- Perform other responsibilities as required by the Department.
- Master’s degree or higher along with 10+ years of experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
- Must have 8+ years of line management experience with statistical professionals.
- Prior CRO Industry experience and previous clinical operations experience (design and implementation of clinical trials are required.
- Extensive experience in statistical design and analysis methodology or basic and complex studies along with extensive experience in leading statistical activities in clinical research.
- Must have experience with regulatory submissions and support; clinical and operational elements of pharmaceutical or Device development; demonstrated ability to foster strategic, collaborative relationships with external stake holders including strategic clients and accounts.
- Must have the demonstrated ability to establish and maintain creidtive and influential relationships with external thought leaders in one or more therapeutic areas.
- Thorough understanding of the principles of ICH GCP and regulatory requirements is essential.