Senior Biostatistician Leader
The position of Senior Biostatistician Leader is responsible for providing strategic guidance and leadership to the biostatistics department, ensuring scientific integrity in clinical trial applications.
Key Responsibilities:
* Deliver high-quality results: lead complex tasks with a focus on accuracy; oversee junior staff with the same expectations.
* Strategic Leadership: serve as biostatistical consultant for department teams; stay current with biostatistics developments and trial methodologies; represent clients at regulatory meetings.
* Operational Management: drive business segment operational pieces; provide expert review of processes; initiate methodology development for statistical standards and validation.
* Customer Engagement: primary point of contact for customers; build and maintain client relationships; consult on operational and statistical programming topics.
* Knowledge Sharing: act as Subject Matter Expert (SME); define training needs and strategic offerings; mentor senior staff; contribute to training materials and rollout at multiple levels.
* Risk Management: identify and mitigate risks to project delivery and quality; manage study-level escalations as needed; escalate as appropriate.
* Database Lock/Unblinding Process: lead database lock/unblinding processes; oversee junior staff; provide expert input on deliverables and data management, including ADaM reviews and sample size considerations.