E.O.N Worldwide

Senior Biostatistician

Research Triangle Park, North Carolina · Senior

Sponsorship not specified$88k-$174kDetected 5 days ago

StatisticsClinical TrialsFDA RegulatorySASLeadershipCollaborationBiostatistics

About the role

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers.
We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Responsibilities

Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met through expert and timely statistical consultancy and support
Provide expert review of study designs, analysis plans, and reports
Assist sponsors in the design of clinical trials, including statistical sections of study protocols, randomization methodology, and writing statistical analysis plans
Provide project support to the statistics reporting process through the specification and review of tables, figures, and listings shells, writing and reviewing derived dataset specifications, and formatting report documents and tabulations
Develop, test, and run SAS programs for the statistical analysis and reporting of clinical study data, including programs for derived datasets, Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, tables, figures, listings, and their validation
Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings
Lead the identification of system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting
Support the development of statistical design and analysis policies
Maintain knowledge of design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, including International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and Committee for Proprietary Medicinal Products (CPMP) points to consider
Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant International Council for Harmonisation (ICH) standards, and specifically with Food and Drug Administration (FDA) Quality System Regulations, including 21 CFR Part 11

Requirements

Validate software in the role of system owner or tester, and test SAS macros while maintaining the required validation and testing documentation
Assist the Director of Biostatistics with all other aspects of the job as required
The job holder must be computer literate and numerate, with a proven ability to adapt to various computer systems
Educated to degree level in mathematics, statistics, or another subject with a strong statistical component
Promotion to the next level is not automatic based on years of experience.
Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Compensation

will fall within the provided range, and it not a guarantee of exact salary.
The final salary will be determined based on relevant experience, performance, education, and internal equity.
In addition to base salary, we offer a competitive benefits package depending on location.
We ensure pay equity and transparency and comply with all applicable labor laws.
Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

Company info

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe.
It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We believe everyone plays an important role in making a world of difference for patients and their caregivers.
From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
What the Senior Biostatistician does at Worldwide:
Independently manages statistical project support and provides expert statistical consultancy across the statistics function.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

Visa & Work Authorization

Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met through expert and timely statistical consultancy and support

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