Statistical Project Leader

Role Summary

Statistical Project Leader (Biostatistics) in Oncology Development. Location: Cambridge, MA. You will lead one or more indications/projects in clinical development and provide statistical leadership under minimal supervision, coordinating with cross-functional teams to ensure statistical integrity of development plans, studies, and submissions.

Responsibilities

• Lead a project/one or several indications of a project in clinical development.
• With minimal direction from senior statistical project leader or team leader, provide statistical support and scientific leadership for responsible projects. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g., regulatory authorities, medical journals), and scientific validity.
• Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload.
• Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
• Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards.

Qualifications

• Education and Experience: PhD or MS in statistics or related discipline with at least 5 years of relevant pharmaceutical experience.
• Technical skills: Broad knowledge and good understanding of advanced statistical concepts and techniques; able to do advanced statistical analyses using SAS or R.
• Soft skills: Demonstrated strong project management, interpersonal and communication skills.
• Languages: Proficient in written and spoken English.