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Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. Visit our website to learn more: www.advancedclinical.com.
We are currently searching for a skilled professional to join a well-known client’s team as a Principal Statistician remotely in the United States. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities
Responsibilities may include the following and other duties may be assigned.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
In development phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
Develops and/or applies statistical theories, methods, and software.
Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
Provides specifications and directions to the clinicians/statistical programmers.
Supports the regulatory review and approval of the experimental therapies.
May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Experience
Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
EDUCATION
Master’s degree or PhD in Biostatistics or Statistics
To Be a Best-fit Your Strengths Must Include
Experience as lead biostatistician in clinical studies
Experience in adaptive study design, analyzing time-series data
Experience in regulatory strategy development/input
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
511239
Required profile
Experience
Level of experience:Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.