Principal Biostatistician REF8998R

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

• The Principal Biostatistician reports to the Director, Clinical Data Sciences and provides biostatistics support to ProPharma Group clients.  
• Essential Functions Include:
• Efficiently and effectively coordinate statistical activities for multiple projects (of any level of complexity) simultaneously, including providing expertise and guidance to relevant aspects of protocol development.
• Develop statistical analysis plans (SAPs), review clinical study reports (CSR), and other relevant biostatistics activities.
• Interact with project team, as well as key internal and external stakeholders.
• Oversee programming of, and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with ProPharma Group or a client's Standard Operating Procedures (SOPs) or study specific guidelines.
• Maintain awareness of project tasks and effectively communicate the status of such tasks to the Director, Clinical Data Sciences and other members of the ProPharma Group executive team as requested.
• Program in SAS and/or R to create output as needed, including presentation-ready tables, listings, and figures.
• Perform other responsibilities as required and participate in process improvement initiatives.
• Maintain a good working knowledge of clinical drug development, ICH and other regulatory guidelines, and biostatistics in order to effectively serve as a statistical department resource.
• Provides input to SOPs development and review.
• Serves as a department resource for complex statistical questions, study design considerations and protocol development.

Qualified candidates must have:

• Master’s or doctoral degree in biostatistics or statistics with 7+ years’ experience to successfully perform the key responsibilities of the role.
• Experience in statistical design, analysis, and reporting methodology for complex studies along with experience in contributing to statistical activities in clinical research.
• Excellent programming skills in SAS and R, including designing and developing output tables, listings, and figures.
• Experience with clinical and operational elements of pharmaceutical development.
• Understanding of the principles of ICH GCP and regulatory requirements is essential.
• Excellent analytical, verbal, and written presentation skills with a thorough working knowledge of SAS, R, and other relevant statistical software as well as working knowledge of Microsoft Office applications including Word, Excel, PowerPoint, and Visio.
• Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
• Experience with regulatory submissions is preferred.
•  Highly effective interpersonal skills and the ability to continually demonstrate poise, tact, and diplomacy are necessary.
• Ability to communicate effectively cross functionally with all members of the clinical study team.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***