Assoc. Director, Biostatistics jobs in United States
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IntePros · 1 week ago

Assoc. Director, Biostatistics

positionCambridge, MA
timeFull-time
remoteOnsite
seniorityDirector/Executive
date12+ years exp

IntePros is seeking an experienced Associate Director, Biostatistics to lead statistical strategy, analysis, and oversight for clinical development programs. The role involves managing a team of biostatisticians and ensuring compliance with regulatory standards while supporting high-profile projects.

ConsultingInformation TechnologyStaffing Agency
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Senior Management
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H1B Sponsor Likelynote

Responsibilities

Collaborate with cross-functional teams to develop statistical strategies for clinical trials (Phases I-IV)
Provide input on protocol design, sample size calculations, and endpoint selection
Contribute to regulatory submissions and respond to agency queries
Lead and mentor a team of biostatisticians, fostering growth and professional development
Assign resources, delegate tasks, and monitor project progress
Conduct performance reviews, provide constructive feedback, and develop training plans
Oversee the development of statistical analysis plans (SAPs) and ensure timely, high-quality deliverables
Review and validate datasets, TLFs (tables, listings, figures), and statistical outputs
Collaborate with Data Management and Programming teams to ensure data integrity
Drive the development of SOPs and best practices for statistical methodologies
Stay updated on industry trends and innovative biostatistical approaches
Lead internal training and knowledge-sharing initiatives
Support proposal development, bid defenses, and client presentations
Build relationships with sponsors, providing statistical expertise and guidance

Qualification

BiostatisticsStatistical programmingLeadershipFDA guidelinesEMA guidelinesICH guidelinesCommunication skillsProblem-solving skillsProject management

Required

Master's or Ph.D. in Biostatistics, Statistics, or a related field
12+ years of experience in biostatistics for clinical trials, with at least 5 years in a leadership role
Expertise in statistical programming languages (e.g., SAS, R)
In-depth knowledge of FDA, EMA, and ICH guidelines
Strong leadership, communication, and problem-solving skills
Proven ability to manage multiple projects and teams simultaneously

Company

IntePros

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IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
dateFounded in 1996
location
Lexington, Massachusetts, USA
people-size201-500 employees
web-link
http://intepros.com

H1B Sponsorship

IntePros has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)

Funding

Current Stage
Growth Stage

Leadership Team

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Loren Kovalcik
CEO
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Company data provided by crunchbase