Principal Biostatistician-Study Lead Remote (Permanent role)

ClinChoice Inc.; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An established industry player seeks a Principal Statistician-Study Lead to join their remote team. In this pivotal role, you will lead statistical activities across clinical trials, ensuring high-quality delivery and compliance with regulatory standards. You will mentor junior statisticians, develop statistical analysis plans, and oversee the accuracy of statistical outputs. This opportunity allows you to contribute significantly to innovative drug development and make a meaningful impact on healthcare. Join a collaborative and inclusive environment that values your expertise and fosters professional growth.

Qualifications

• MS or PhD in Statistics or Biostatistics required.
• 4-5 years experience with PhD or 9-10 years with MS.

Responsibilities

• Lead statistical activities across clinical trials from design to reporting.
• Guide junior statisticians and ensure quality in statistical analyses.

Skills

Statistical analysis

Communication skills

Statistical concepts and methodologies

Mentoring

Education

MS in Statistics

PhD in Statistics

Job description

United States

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Principal Statistician-Study Lead on a permanent basis. (remote)

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

1. Lead statistical activities across clinical trials or observational studies, from design through to reporting.
2. Serve as the primary statistical contact for cross-functional study teams and client stakeholders.
3. Develop statistical analysis plans (SAP), TFL shells, and ensure accurate implementation.
4. Guide and review work of junior statisticians and programming teams.
5. Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
6. Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
7. Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
8. Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
9. Responsible for validity of analysis and explore alternative analysis strategies as needed.
10. Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
11. Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
12. Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
13. Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
14. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Education and Experience:

1. MS or PhD in Statistics, Biostatistics or related field. PhD with 4-5 years of experience or MS with 9-10 years of experience.
2. Strong experience with any Therapeutic area.
3. Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
4. Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
5. Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Principal #FTE

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