LanceSoft, Inc. ยท 4 months ago
Sr Statistician - Exempt
LanceSoft, Inc. is seeking a Senior Statistician to join their team in Mounds View, MN, where you will support innovative cardiovascular device clinical trials. The role involves validating statistical analyses, designing biostatistical plans, and contributing to advanced analytics and data solutions.
Information Technology
Responsibilities
Validate statistical analyses performed by other team statisticians using R or SAS programming languages
Design, plan, and execute biostatistical components of plans for research and development projects, establishing conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products
Use sound statistical methodology to conduct studies relating to the life cycle of the product
Prepare the statistical component of protocols in development-phase projects, meeting project objectives, health authority guidelines, and clinical trial methodology standards
Develop and/or apply statistical theories, methods, and software
Summarize and interpret data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes, and methods used
Provide specifications and directions to clinicians/statistical programmers
Support the regulatory review and approval of experimental therapies
Partner in trial design and establish standards for clinical conduct, and the collection, management, and/or reporting of data
Qualification
Required
Bachelor's degree with a minimum of 4 years of statistical experience (e.g., statistical modeling, biostatistics)
OR
Advanced degree with a minimum of 2 years of statistical experience (e.g., statistical modeling, biostatistics)
Preferred
Master's degree (or above) in statistics/biostatistics or relevant fields
2 years post-graduate experience in medical research
Understanding of statistics and machine learning methods, ability to continue self-learning of technical and non-technical skills
Demonstrated proficiency in SAS, R or Python and experience with low-level languages, including C/C++
Prior experience in FDA and/or global regulatory submissions
Experience with adaptive designs, Bayesian modeling, sequential data, computational statistics
Experience in processing large data from various data sources
Experience in handling of protected patient health information
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR, CFR)
Insatiable desire to learn, innovate, and challenge themselves for the benefit of patients
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
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 StageCompany data provided by crunchbase