Principal Biostatistician (FTE or Contract)

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.

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.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

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

Take the first step towards your dream career. Here is what we are looking for in this role.

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