Worldwide Clinical Trials

Principal Biostatistician

Worldwide Clinical Trials$96K — $191K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • PhD or postgraduate degree in a scientific field preferred; Bachelor's degree with 12+ years of related experience required.
  • Excellent SAS programming skills.
  • Proficient in WinNonlin, nQuery, Microsoft Word, and Excel.
  • Solid understanding of Good Laboratory Practice (GLP) guidelines and FDA regulations.
  • Ability to write clear and concise study reports and communicate effectively with various stakeholders.
  • Strong organizational skills with a focus on problem-solving and prioritization.

Responsibilities

  • Design clinical studies and prepare statistical analysis plans.
  • Perform statistical analyses on clinical and pharmacokinetic data using relevant software.
  • Train and guide junior staff in necessary techniques and methodologies.
  • Prepare comprehensive reports including analyses, graphs, and tables.
  • Interact with interdisciplinary teams regarding study design and data interpretation.
  • Identify and proactively resolve issues in statistical documentation and analyses.

Benefits

  • Comprehensive benefits package depending on location.
  • Commitment to pay equity and transparency.
  • Opportunities for professional development and career advancement.
Full Job Description
WhatThe 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 your 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.

About Worldwide Clinical Trials

Worldwide Clinical Trials is a global contract research organization (CRO) that provides clinical research services to pharmaceutical and biotechnology companies. They specialize in early phase development, late phase development, and full-service clinical research. Worldwide Clinical Trials has experience in a wide range of therapeutic areas, including oncology, neuroscience, and infectious diseases. They are committed to providing high-quality, efficient, and cost-effective services to their clients.
Learn more about Worldwide Clinical Trials
Size
1,500 employees
Industry
Founded
1986

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