Description
At eClinical Solutions, our goal is to leverage technology to accelerate clinical research and bring life-changing therapies to patients faster. Our industry-leading elluminate® clinical data platform is used by top life sciences companies worldwide to regain control of their data and provide meaningful analytical insights.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate®, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.
Overview of the position:
Senior Biostatisticians will work closely with the Lead Statistician and provide support for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan (including table, listing, and figure shells), randomization schedule, conducting statistical analyses, validating programming and reporting output, developing statistical analysis reports, and performing quality control on tables, listings and figures. Senior Biostatisticians will also work on specifications and statistical programming for the development of analysis datasets specific to trial reporting requirements. Senior Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.
KEY TASKS & 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 in support of the lead 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
- Support in the development and/or review of the statistical analysis plan
- Conduct the statistical review of 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, support the development and validation of the study specific list of table and table shells for clinical study reports and for study specific deliverables
- 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
- Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
- Other duties as assigned
Education/Language:
- Master in Statistics, Biostatistics, or related field
- Excellent knowledge of English
Professional Skills & Experience
- Minimum 3+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role
- 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
- Familiarity with ICH guidelines and other guidelines such as Google Cloud Platform, 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 with 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
- Excellent team player
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared you our story, 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.
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