Job Description
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.
You will make an impact:
As a Principal Biostatistician, you will be responsible for working 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, reporting output, and developing statistical analysis report. You will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. You 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
- Provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
- 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
- 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
- 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 and 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. Thorough understanding of SDTM data structures
- Experience delegating tasks, leading projects, and working on multiple clinical protocols at the same time
- Ability to balance conflicting priorities
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
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.
