Senior Director, Biostats (BME)
Job Location: NJ
Promote statistical methodology in the global oncology TA Identify innovative approach of interest for the oncology early development portfolio, collaborate with leadership in other departments to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on division or corporate-wide teams.Direct statistical support and provide scientific leadership for one or more projects of clinical development. Ensure project teams have high quality statistical support for creation of clinical development plans (CDP), study design, analyses and operational aspects. Design and execution of CDPs consistently meeting internal guidelines and regulatory requirements. Maintain awareness of industry standards and regulatory requirements and novel methodologies/technologies. Oversee process for statistical reporting. Review Statistical Analysis Plan (SAP), Key Results, Clinical Study Report (CSR), and integrated summaries. Ensure compliance with data submission guidelines. Summary documents adequately address major project objectives and are consistently delivered on time. Manage the performance and career development of subordinates. Inspire and motivate team. Takes stand on important issues in productive, respectful way. Promote teamwork, quality, and innovation. Create productive work environment. Ensure staff compliance with SOPs and departmental standards.
Requirements & Qualifications:
PH.D. (MS) in statistics or related discipline with 8+ (10+) years of pharmaceutical experience, including significant interaction with both FDA and EMEA and successful project track records. Experience in oncology clinical development. Direct people management experience preferred, but indirect people management as project leader can be surrogate. Excellent verbal, writing, and presentation skills.
Please contact Bill Emker at email@example.com
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