Senior Director, Biostatistics (Boston, MA)
Position Summary:
As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership role, you will oversee the development, execution, and interpretation of statistical analyses, maintaining data quality, analysis integrity, and compliance with regulatory requirements. Additionally, you will champion innovative trial designs and methodologies while fostering a collaborative, high-performing team culture. Reporting to the VP, Head of Biometrics, you will play a pivotal role in shaping clinical development strategy and achieving company goals.
Key Responsibilities:
Build, mentor, and lead a high-performing statistical team, fostering collaboration, learning, and accountability.
Provide strategic and statistical leadership as a core member of the clinical development team, collaborating with cross-functional stakeholders.
Partner with medical, regulatory, pharmacology, clinical operations, and other functions to implement appropriate statistical methodologies and analysis plans.
Champion innovative statistical approaches, such as adaptive, seamless, and Bayesian designs, to enhance trial efficiency and success rates.
Ensure the accuracy, integrity, and consistency of statistical analyses across clinical development programs, from Phase I through regulatory submissions and post-approval activities.
Contribute to the development and implementation of Standard Operating Procedures (SOPs) and workflows, ensuring regulatory compliance and adherence to industry best practices.
Oversee CRO activities, ensuring high-quality deliverables, adherence to timelines, and efficient use of resources.
Requirements:
Ph.D. in Biostatistics or Statistics with 10+ years of industry experience, or Master’s degree with 12+ years of experience.
Proven expertise in statistical activities for clinical development programs, including successful regulatory submissions (NDAs, BLAs, or equivalent).
Demonstrated leadership in applying innovative statistical methodologies to enhance clinical trial efficiency.
Department: Direct Clients
This is a full time position
Recommended Jobs
Skilled Carpenter Needed!
We are seeking a highly motivated, detail-oriented individual for the role of skilled carpenter. This carpentry position will include frame to finish in a commercial or residential setting. Job …
Senior Engineer
Akkodis is seeking a Senior Engineer for a Contract with a client in Waltham, MA. You will be responsible for managing and troubleshooting Azure AD Connect synchronization policies and planning…
School Van Driver
Van Pool Transportation LLCA Driver is responsible for transporting clients from their pickup point to their destination in a timely and safe manner. Using a vehicle to successfully transport people,…
Telecommunications Specialist - Community Hospitals
POSITION SUMMARY : Telecom Specialist will be responsible for day to day operations for BMCHS which includes Boston Medical Center campus and Boston Medical Center Healthnet Plan. They will des…
Temporary Outage Manager Support
If you have what it takes to become part of the Vistra family and would like to start a promising career with a global leader, take a look at the exciting employment opportunities that are currently …
Marketing Director - Technical & Field Services
The Marketing Director - Technical & Field Services is responsible for overseeing and coordinating marketing efforts for Clean Harbors' Technical Services and Field Services organizations. Reporti…
Optician
Optician Full-Time Will rotate between East Boston and South Boston sites. The Optician is responsible for the daily operations of the dispensary, assisting customers/patients aged 2 – 100 i…
CDL Front Load Driver
Join Waste Connections, a leader in integrated waste services. As a CDL Front Load Driver, you will play a crucial role in our commitment to providing reliable and efficient waste management services.…
Program Manager
Overview The Pathfinder office at Dana-Farber/Harvard Cancer Center (“DF/HCC”) aims to strengthen training opportunities for DF/HCC researchers at all career stages by utilizing the exceptional …
Psychometrist
About Wells Child Psychology I am a small but growing autism/developmental assessment practice located in Norwood, MA but with testing locations in West Springfield, Worcester, Wayland, and Burli…