Purpose and Passion
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.
Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.
About this role :
The Senior Manager, Biostatistics provides, leadership, strategy, expertise and oversight of biostatistics and statistical programming for clinical studies.
Designs, plans and executes biostatistical components for clinical studies, including preparing the components of protocols related to statistical design and analysis, and the statistical analysis plan, which meet project objectives, health authority guidelines, and clinical trial methodology standards.
Is also responsible for the statistical components of clinical study reports.
Your responsibilities will include :
Takes an active role in assisting the clinical department to define their strategy for clinical studies.
Oversees biostatistical aspects of study design and hypothesis development.
Oversees the quality of the statistical design and analysis and ensures that worldwide processes are implemented in compliance with applicable regulations.
Provides guidance or interface directly with regulatory authorities (e.g. FDA) on statistical aspects of study design, hypothesis testing, and study results.
Recruits, trains, develops and mentors team members.
Monitors regulatory initiatives (US and international) and innovative practices that impact biostatistics and implements appropriate changes to the groups’ practices to ensure regulatory compliance.
Interfaces with vendors to ensure quality of their biostatistics and statistical programming activities.
Manages timelines for statistical deliverables in coordination with vendors and cross-functional project teams.
Participates in the evaluation and selection of vendors for outsourced statistical activities.
Reviews and approves key statistical deliverables, including statistical exhibits (tables, figures and listings).
Provides input for planning and management of budgets for biostatistics deliverables.
What we’re looking for in you :
Postgraduate degree or appropriate equivalent experience in statistics required
Minimum 10 years of work experience in the pharmaceutical or medical device industry
Extensive experience with preparation and interactions with regulatory agencies
Team management experience
Oncology study experience
Experience with CRO oversight
Skilled in organization and prioritization with a strong attention to detail
Ability to deliver accuracy and high quality of work under pressure of tight deadlines and heavy workload and work on multiple tasks simultaneously
Excellent interpersonal, written and oral communication skills