Statistician III

General Summary

Under supervision of the Statistics Project Manager or higher, a Statistician III will analyze and interpret basic and advanced statistical analyses of clinical data accurately. The incumbent will understand all roles/tasks of a statistician in a clinical trial and identifies ways to proactively problem solve. This role will liaise with medical writers and study investigators in preparing research manuscripts for publication.

Acts as a mentor to team members.

• Writes analysis plans and report specifications with minimal guidance.
• Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
• Uses statistical and medical understanding to propose and perform additional analyses appropriately.
• Demonstrates willingness and flexibility to try new statistical methods when analysis needs change. Keeps abreast of new statistical methods and techniques by attending conferences and workshops, opportunity permitting.
• Seeks guidance for analyses appropriately.
• Writes own SAS and/or R code, finds errors, corrects, and validates output and results.
• Considers alternative programming approaches to improve quality and/or efficiency.
• Mentors less experienced programmer and/or statisticians.
• Furthers programming skills independently.
• Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
• Understands priorities and manages all project responsibilities independently.
• Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
• Communicates appropriately with team members, external department or vendors, and supervisors on a regular basis.
• Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group.
• Serves effectively on company-wide committees, opportunity permitting.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

* Indicates an essential function of the role

PhD in Statistics, Biostatistics, Mathematics or related discipline or Master’s degree with 4+ years of experience or Bachelor’s degree plus 5+ years of experience in data analysis or equivalent combination of education and experience.

• Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
• Uses statistical and medical understanding to propose and perform additional analyses appropriately.
• Demonstrates willingness and flexibility to try new statistical methods when analysis needs change. Keeps abreast of new statistical methods and techniques by attending conferences and workshops, opportunity permitting.
• Seeks guidance for analyses appropriately.
• Writes own SAS and/or R code, finds errors, corrects, and validates output and results.
• Considers alternative programming approaches to improve quality and/or efficiency.
• Mentors less experienced programmer and/or statisticians.
• Furthers programming skills independently.
• Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
• Understands priorities and manages all project responsibilities independently.
• Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
• Communicates appropriately with team members, external department or vendors, and supervisors on a regular basis.
• Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group.
• Serves effectively on company-wide committees, opportunity permitting.
• Ability to work effectively under tight timelines and schedules.
• Ability to work independently and as a contributing team member.
• Ability to determine methods and procedures on new assignments and may coordinate activities of other personnel.
• Strong oral, written, and interpersonal communication skills.
• Proficiency with MS Word, Excel, and PowerPoint.
• Excellent organizational skills with ability to prioritize assignments while handling various projects…