Penfield Search Partners
Our client is a leader in the Next-Generation Sequencing and Diagnostics technologies that have the potential to impact data analysis and patient care across many therapeutic areas and disease states. They are currently seeking an experienced Statistician at the Director or Associate Director level to lead and manage a team of Biostatisticians department to support analytical and clinical validation studies to achieve regulatory approval of IVD and companion diagnostic assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval).
Provide strategic and statistical leadership on study designs, statistical analysis plans, data analyses and statistical reports consistent with regulatory requirements for companion diagnostic product development and validation.
Manage and develop the Biostatistics team, providing guidance on:
o Statistical designs for clinical and analytical studies based on regulatory guidance or CLSI (Clinical and Laboratory Standards Institute) standards
o Utilization of appropriate statistical tools and techniques
o Presentation of study results in oral and written form
Provide team mentoring, performance reviews and recruiting
Collaborate with cross-functional teams on complex or unique study designs, strategies, and analysis approaches.
Review and edit study protocols, statistical analysis plans and study reports.
Write and review content for regulatory submissions
MS degree and 12+ years or a PhD with 8 years experience
2+ years of people leadership experience
Able to effectively lead a team and mentor others
Proficiency in at least one statistical analysis software package (e.g. SAS, JMP scripting, R)
Excellent verbal and written communication skills for both technical and non-technical audiences; able to communicate ideas, analysis results, and conclusions effectively
Able to independently prioritize work and complete deliverables to timelines
Broad expertise in a statistics field or demonstrate excellence in areas of statistics relevant to development and evaluation of companion diagnostics or IVDs
Experience leading a statistics team to support product development in diagnostic, medical device or biopharmaceutical industry is highly desirable
Experience in the field of oncology or knowledge of NGS technology is a plus