Principal Biostatistician

INC Research; King of Prussia (PA); On-site; USD 75,000 - 95,000; Full time

Job summary

INC Research is seeking a Biostatistician who will provide biostatistics consulting throughout all phases of drug development, ensuring compliance with regulatory requirements. The ideal candidate will have a Ph.D. in Biostatistics or an MS with considerable experience.

The role involves close collaboration with senior management, mentoring junior staff, and presenting findings at industry meetings. Strong knowledge in FDA/ICH regulations and statistical software like SAS is essential, alongside excellent leadership and interpersonal skills.

Qualifications

• Requires a Ph.D. in Biostatistics or equivalent with clinical trials experience.
• In-depth knowledge of FDA/ICH regulations.
• Expert knowledge of SAS and data management.

Responsibilities

• Provide biostatistics consulting for drug development.
• Assist in developing policies for biostatistics activities.
• Interact with senior management on operational issues.

Skills

Biostatistics consulting

FDA/ICH regulations

SAS

Data management

Microsoft Office Suite

Interpersonal skills

Education

Ph.D. in Biostatistics or equivalent

MS degree with more experience

Tools

SAS

StatXact

Nonlin

EaSt

Job description

INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents, and we’ll do it for you too.

Job Description

• Provides biostatistics consulting in the design of protocols, drug development plans, and in the analysis and reporting of clinical trial data for all phases of drug development research.
• Assists in the development of policies, procedures and standards for biostatistics activities. Supports the development and implementation of standard operating procedures and training program for staff.
• Participates in the sales and marketing function as it relates to operational activities. Provides input and review/approval of study proposals upon request.
• Interacts with senior management of pharmaceutical and biotechnology sponsors on operational issues.
• Develops articles and presentations to be published in statistical journals and industry publications to promote the processes and technologies deployed by the biostatistics department.
• Ensures compliance with Good Clinical Practices, sponsor contracts as well as all Food and Drug Administration, and International Conference on Harmonization requirements.
• Maintains activity and visibility level providing representation for Company at professional meetings, including presentations at industry meetings, and other meetings relating to ICH issues or worldwide trends in biostatistics.
• Acts as mentor and technical expert to junior biostatisticians and programming staff. Provides leadership, quality review, and mentoring to less experienced biostatisticians and coordinates the work of other biostatisticians.

Qualifications

• Requires a Ph.D. in Biostatistics, or in science with statistics minor or equivalent, plus moderate design and analysis of clinical trials experience in a Contract Research Organization or Pharmaceutical/ Biotechnology company OR an MS degree plus more experience, or equivalent in education and experience.
• A nominal amount of supervisory experience preferred.
• Requires in-depth knowledge and application of FDA/ICH regulations and experience in interacting with the FDA.
• Expert knowledge of major statistical software program, e.g. SAS is necessary.
• Strong working knowledge of other software such as StatXact, Nonlin and EaSt is preferred.
• Experience preparing and submitting regulatory documents is required.
• Data management experience is preferred.
• Highly effective presentation, documentation, negotiation, interpersonal and leadership skills with a team-oriented approach are necessary.
• Strong computer skills in Microsoft Office Suite are necessary.
• The ability to prioritize and handle multiple tasks in a dynamic environment is essential.