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eClinical Solutions brings people & data together to support tomorrow’s breakthroughs with clinical data software and clinical biometrics services.

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We offer a comprehensive range of software and services designed to maximize the value of your clinical data. Our innovative products and platform, elluminate, enable faster insights and streamline the entire data lifecycle from acquisition to analytics. With Mapper, you can easily map and standardize data without the need for programming. Data Central provides integrated data review and management capabilities, while Clinical Analytics offers in-depth clinical and operational analytics across multiple sources. Operational Insights allows you to manage your trial operations in a data-driven manner, and Risk-Based Quality Management ensures holistic risk management and monitoring. Our services, including clinical biometrics and statistical programming, are expertly accelerated by the latest technologies. With eClinical Solutions, you can digitize and transform your clinical data, empowering new discoveries and therapies in the life sciences industry. Request a demo today to experience the power of our products and services for yourself.

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eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

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.

Principal Biostatistician (FTE or Contract)
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**OVERVIEW**

The Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

**Your day to day:**

*   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

**Qualifications:**

*   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
*   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

**Work Arrangement:**

Remote

**Compensation:**

US Pay Range: $175,000 - $215,000 USD

**AI Use Statement**

Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.

Senior Corporate Recruiter @ eClinical Solutions | Recruitment, Talent Acquisition

Alicia Brown

Senior Corporate Recruiter

Talent Acquisition Specialist/Consultant | End-to-End recruitment| Built Sr/Mid/Leadership teams(In-house/Latrel hiring)| Metrics-led outcomes | Skilled negotiator| Strategic professional.

Pavan Kumar

Senior Corporate Recruiter | Talent Acquisition | Technical talent sourcing and hiring | End to End recruitment Cycle | Product Analytics

Kanaka Mahalakshmi

Senior Manager, People Operations

Principal Biostatistician (FTE or Contract) - Greenhouse

Project Manager

Statistical Analysis

The Principal Biostatistician will provide consulting services for statistical analysis and programming related to clinical trials, including developing statistical analysis plans and conducting analyses.

Principal Biostatistician

Data

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