eClinical Solutions · 1 month ago
Principal Biostatistician
United States
Full-time
Remote
Lead/Staff
$150K/yr - $175K/yr
10+ years expeClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. The Principal Biostatistician will provide high-level consulting services for statistical analysis, reporting, and programming specific to clinical trials, ensuring all deliverables meet or exceed client expectations.
Big DataHealthcareInformation TechnologyPharmaceuticalProfessional ServicesSoftwareAnalyticsHealth Care
Responsibilities
Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
Develop, review, and finalize the statistical analysis plan
Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
Develop randomization schedule, specifications, and guidelines
Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
Other duties as assigned
Qualification
Required
Strong experience with clinical study design development, analysis, and sample size determination
Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
Excellent knowledge of English and with clear, concise, and accurate communications, both written and verbal
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
Ability to balance conflicting priorities
Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures
Preferred
Master in Statistics or biostatistics preferred
SAS® certification is preferred
10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
Benefits
EClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work!
We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance.
Company
eClinical Solutions
eClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics. It is a sub-organization of GI Partners.
201-500 employees
H1B Sponsorship
eClinical Solutions 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
66%
Represents job field similar to this job
Engineering and Development
Management and Executive
Product Management
Customer Service and Support
Trends of Total Sponsorships
*2026 (3)
2025 (10)
2024 (7)
2023 (8)
2022 (5)
2021 (5)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
GI PartnersSummit Partners
2024-09-12Private Equity
2024-09-12Acquired
2020-01-21Private Equity
Leadership Team
Raj Indupuri
CEO and Co-Founder
Sam Anwar
Chief Technology Officer
Recent News
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