Job Description

Biostatistician Manager - Neuro

• Work with the clinical study team on study design, development and/or review of clinical study protocols.

• Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies;

• Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.

• Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed.
  Perform exploratory analyses to support drug development strategy.

• May work on submission teams as a statistician and/or a programmer.

• Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies

• Will serve as lead Statistician on complex trials and across multiple studies.

• Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.

• Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.

QUALIFICATIONS NEEDED:

• Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 3 years of experience in the pharmaceutical, CRO or biotech industry.
• Demonstrated excellence in statistical skills
• Neuro experience is preferred
• Ability to effectively work on multiple projects
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and leads problem solving within the team

Additional Information

All your information will be kept confidential according to EEO guidelines.