Principal Biostatistician

OCUGEN OPCO INC • Malvern, PA

118d

About The Position

The Principal Biostatistician is a key member of Ocugen’s clinical development team. This individual will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods given the hypothesis and available data through programming in SAS, or R. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs of the clinical studies.

Requirements

• MS/MA degree in Biostatistics.
• 5+ years of research experience working as Biostatistician, or Statistical Programmer.
• Ability to synthesize results in graphic, oral, and written reports.
• Exceptionally strong statistical programming in SAS.
• Experience programming in other languages, such as R, SQL, Matlab.
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

Responsibilities

• Collaborates on implementation and analysis of statistical aspects of research protocols.
• Provides statistical consultation for clinical programs.
• Performs sample size and power calculations, and provides input on Study Protocols.
• Develops statistical analysis plans, including detailed textual description of planned analysis and mock-ups of data displays.
• Assists in development of CRFs, programming specifications, and additional study documents related to data flow and analyses.
• Performs statistical analyses, including hypothesis testing and modeling.
• Provides tabular and written summaries of analyses and statistical methodology.
• Reviews and provides comments on statistical summaries.
• Interface with CRO ensuring data and statistical reporting is secure and timely.
• Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met.
• Ensures that project tasks are completed with acceptable quality.
• Attends team meetings and represents departmental needs for assigned projects.
• Participate in study and department meetings.
• May assist in developing policies and procedures (SOPs).
• Additional tasks and projects as requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 51-100 employees