Principal Biostatistician

Worldwide Clinical Trials; North Carolina; On-site; USD 97,000 - 192,000; Full time

Job summary

Worldwide Clinical Trials in the United States is seeking a Principal Scientist, Biostatistician to apply independent judgment and lead statistical analysis across pharmacokinetic and clinical studies.

You'll design studies, develop analysis plans, run analyses with SAS, WinNonlin, and other software, and contribute to publications and intellectual property while guiding project teams.

Qualifications

• Familiarity with GLP and FDA guidance for statistical analyses, pharmacokinetic studies, and reports.
• Excellent SAS programming skills.
• Proficient with WinNonlin, nQuery, Word and Excel.
• Ability to read, write, and understand complex literature.
• Ability to write concise study reports and communicate clearly with stakeholders.

Responsibilities

• Accurately and efficiently perform broad-ranging statistical tasks.
• Design clinical studies and construct data analysis plans to meet protocol requirements.
• Perform statistical analyses on clinical and pharmacokinetic data using appropriate methods and software.
• Prepare documentation for final reports with text, tables, graphs and outputs.
• Interact with clients and project teams regarding study design and analyses.
• Lead interdisciplinary project teams and guide junior personnel.

Skills

SAS programming

Organizational skills

Communication skills

Literature review

Problem-solving

Education

PhD or postgraduate degree with a scientific focus

Bachelor’s degree with scientific focus + 12+ years experience

Tools

WinNonlin

nQuery

Microsoft Word

Microsoft Excel

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 Principal Scientist, Biostatistician does at Worldwide

Use independent judgment and technical expertise to assist in designing studies; preparing statistical analysis plans; analyzing data from pharmacokinetic, clinical, and pre‑clinical studies; interpreting statistical results from pharmacokinetic, clinical, and related analyses; and generating randomization schedules for clinical studies.

Principal Scientists are recognized as scientific leaders in the company. They regularly contribute to literature and to building Worldwide Clinical Trials’ intellectual property and are capable of leading interdisciplinary project teams.

What You Will Do

• Accurately and efficiently perform tasks that are broad in scope
• Use knowledge and judgment to reach well‑defined goals in project management
• Work independently and collaboratively to solve technical problems by implementing contemporary methods
• Assist the clinic, method development, and marketing/business development by applying knowledge, conducting literature reviews, providing information, and offering related support
• Train and guide less experienced personnel in techniques required for work assignments
• Supervise personnel involved in statistical and pharmacokinetic‑related work
• Assist with the design of clinical studies and construct data analysis plans to meet study protocol requirements and maximize information from available data
• Perform statistical analyses on clinical and pharmacokinetic data using appropriate methods and software programs
• Prepare documentation for final reports, including text, tables, graphs, and analysis outputs
• Interact with clients, bioanalytical personnel, and clinical personnel regarding study design, statistical analyses, pharmacokinetic data analyses, and data interpretation
• Identify problems or potential problems in generating quality statistical and pharmacokinetic documents, report concerns to their supervisor, and propose possible solutions
• 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

• Familiarity with corporate policies, goals, and objectives, normally acquired after three months of exposure to Worldwide Clinical Trials’ operations
• Understands and applies Good Laboratory Practice (GLP) guidelines and U.S. Food and Drug Administration (FDA) guidance documents pertinent to statistical analysis, pharmacokinetic studies, pharmacokinetic analyses, and reports
• Excellent SAS programming skills
• Proficient in the use of WinNonlin, nQuery, Microsoft Word, and Microsoft Excel
• Ability to read, write, and understand complex literature
• Ability to write concise, understandable study reports and communicate clearly with clients and Worldwide Clinical Trials personnel
• Ability to create, understand, and interpret graphs, tables, and charts
• Strong organizational and problem‑solving skills and ability to set priorities
• Ability to interact effectively with superiors, peers, and others and communicate ideas clearly
• Ability to follow and implement Worldwide Clinical Trials’ policies and Standard Operating Procedures, normally associated with three months of experience at Worldwide Clinical Trials

Your Experience

• PhD or postgraduate degree with a scientific focus preferred
• Bachelor’s degree with a scientific focus and 12 or more years of relevant work experience required

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.

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 - $96,500.00 - $191,500.00

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.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.