LanceSoft, Inc. · 2 months ago
Biostatistician, Clinical Affairs
Herndon, VA
Full-time
Onsite
Senior Level
$60/hr - $80/hrLanceSoft, Inc. is a company that specializes in providing statistical support for clinical studies. They are seeking a Biostatistician to lead a team, develop statistical methodologies, and ensure compliance with regulatory requirements in the medical device industry.
Information Technology
Responsibilities
Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians
Develop and implement statistical methodologies for sample size calculations and power analysis
Generation of randomization schedules
Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies
Manage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations
Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs
Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures
Review and provide input to study protocols, and clinical study reports
Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims
Ensure compliance with regulatory requirements and industry standards for statistical practices
Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts
Stay updated with the latest advancements in biostatistics and medical device regulations
Deliver special projects / ad-hoc reporting as needed
Qualification
Required
Deep understanding of statistical methodologies
Sample size calculations
Regulatory requirements within the medical device industry
Strong leadership skills
Ability to navigate complex analyses
Proficiency in statistical software
Strong communication/presentation skills
Support senior leaders in data analytics
Lead and manage the biostatistics team
Provide guidance and mentorship to junior biostatisticians
Develop and implement statistical methodologies for sample size calculations and power analysis
Generation of randomization schedules
Order, collate and interpret large volumes of diverse data
Perform exploratory and confirmatory statistical analysis for studies
Manage various datasets
Determine summary statistics
Conduct hypotheses testing
Estimate statistical models
Report formats and other analysis considerations
Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs
Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures
Review and provide input to study protocols and clinical study reports
Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing
Ensure robust statistical support for product validation and claims
Ensure compliance with regulatory requirements and industry standards for statistical practices
Present findings and statistical insights to stakeholders, including senior management and regulatory bodies
Effectively communicate statistical concepts
Stay updated with the latest advancements in biostatistics and medical device regulations
Deliver special projects / ad-hoc reporting as needed
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
Founded in 2000
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase