Sr Director, RWE Biostatistics - Madison, United States - BioSpace

Description

Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, cell therapy, immunology, Neuroscience, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

The Senior Director of Real-World Evidence Biostatistics plays a pivotal role in leading and overseeing the strategic direction and execution of statistical and real-world evidence initiatives within the organization. This key leadership position involves providing guidance and expertise in statistical methodologies, study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products. The Senior Director collaborates closely with cross-functional teams to drive innovation, optimize trial design, and leverage real-world data to support evidence generation and decision-making. Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.

Key Responsibilities

• Provide strategic leadership in the design, execution, and analysis of real-world evidence studies
• Lead efforts to enhance the utilization of real-world data for evidence generation and decision-making purposes
• Represent the organization at conferences, forums, and industry events to showcase expertise and thought leadership in biostatistics and real-world data
• Manages resources and budget to ensure company resources are allocated according to the development needs and priorities
• Creates effective processes related to RWE and ensures consistency and adherence across therapeutic areas and projects
• Key contributor to Clinical Development Plans, submissions, and post-submission strategies/preparation/ defense as needed
• Represents the company in interfaces with regulatory agencies globally
• Effectively engages as a matrix team member on high-level development teams and serves as a scientific and strategic partner
• Seeks and establishes new collaborations with cross-functional teams for RWE objectives
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner
• Provides leadership to empower and develop the team
• Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff

Qualifications & Experience

• PhD or MS (12+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis
• Extensive experience in real-world data within the pharmaceutical or CRO industry, demonstrating a strong track record of leadership and strategic thinking.
• In-depth knowledge of statistical methodologies, clinical trial design, and real-world evidence generation, with a focus on optimizing study design and data analysis
• A commitment to continuous learning and professional development in the field of real-world data
• Experience in preparing and participating in global regulatory agency interactions
• Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills
• At least 5 years management (direct or matrix) experience is preferred

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.