Senior Statistician

Worldwide Clinical Trials Holdings, Inc.; North Carolina; Hybrid; USD 88,000 - 174,000; Full time

Job summary

Worldwide Clinical Trials Holdings, Inc. is seeking a Senior Statistician to independently manage statistical project support and act as a statistical consultant across multiple studies.

The role emphasizes leadership, study design evaluation, and advanced data analysis using SAS and SDTM/ADaM standards. Applicants should hold a Master’s degree in statistics or mathematics and have at least 3 years of trial experience.

Qualifications

• Master's degree in mathematics, statistics, or a related field is required.
• Minimum 3 years of statistical experience leading clinical trial projects and data analysis.
• Expert-level project statistics leadership and consultancy across projects.

Responsibilities

• Manage statistics support for one or more projects/sponsor programs with expert statistical consultancy.
• Provide expert review of study designs, analysis plans, and reports.
• Assist sponsors in designing clinical trials, including protocol sections and SDTM/ADaM data.
• Consult with internal departments, sponsors, and third parties on statistical issues and reporting.
• Prepare final reports with tables, listings, figures, and datasets.
• Develop, evaluate, and run SAS programs for analysis and reporting of study data.
• Ensure documentation maintenance and validation of programs.
• Produce ad hoc data summaries during trials.
• Lead system/process improvements for data processing and reporting.

Skills

Expert-level project statistician

Statistical leadership

Design & analysis consultancy

SAS

nQuery

Regulatory guidance (ICH FDA CPMP)

Education

Master's degree in mathematics or statistics

Tools

SAS

nQuery

Job description

Who we are

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 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 prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Senior Statistician does at Worldwide

Independently manages statistical project support and provides expert statistical consultancy across the stats function.

What you will do

• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are met by expert and timely statistical consultancy and support
• Provides expert review of study designs, analysis plans, and reports
• Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology, and writing statistical analysis plans
• Consult with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements
• Provide project support to the statistics reporting process through the specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations
• Undertake the preparation of final reports, including the production of tables, listings, and figures, and report writing
• Develop, evaluate, and run Statistical Analysis System (SAS) programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM) datasets, tables, figures, and listings, and their validation
• Ensure the maintenance of documentation, e.g., the description of programs and validation
• Produce ad hoc data summaries when requested during a trial.
• Extract information from the system during a trial, e.g., summaries, data listings, study data sets.
• Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation
• Make statistical contributions to manuscripts for publication/presentation
• 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 in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, e.g. International Council for Harmonization (ICH), Food and Drug Administration (FDA), and Committee for Medicinal Products (CPMP) points to consider
• Assist with Quality Assurance and Audit requirements
• Assist the Director of Biostatistics with all other aspects of the job as required
• Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulation (including 21CFR Part 11)
• Perform other duties as assigned.
• The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you bring to the role

• Computer literate and numerate with a proven ability to adapt to various computer systems
• Expert-level project statistician experienced in providing statistical leadership to projects
• Design and analysis consultancy skills and knowledge across a broad range of applications, together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change
• Your experience: Master's level in mathematics, statistics, or another subject required with a strong statistical component
• Minimum 3 years of statistical experience leading clinical trial projects and data analysis

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $87,500.00 - $173,500.00 The salary range provided is intended to give candidates an understanding of potential earnings. 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. We love knowing that someone is going to have a better life because of the work we do.

Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.