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Sr. Biostatistician  (Science & Biotech)
San Francisco , CA 94016
Recruited by: Melissa Grover | Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat Inc.
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Feb 08, 2019
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Job Description

Onsite - San Francisco, CA
Direct Hire

The Senior Biostatistician will provide statistical support (e.g., study design and data analysis) across all clinical studies, pre-clinical, and validation studies. The successful candidate will provide data mining for product development, global regulatory submissions, claims substantiation, post market surveillance, and tracking data optimization. These activities are in direct support of product approval for drugs.

Responsibilities:

Assist the Director of Biostatistics with the design and analysis of clinical trials in healthy volunteers and patients
Provide biostatistics leadership to cross-functions, i.e. clinical science, project management, medical affairs, pharmacovigilance, and clinical operations
Author statistical analysis plans for individual studies, ISS and ISE
Provide input into CDISC standards across studies and programs
Collaborate on project development plans, regulatory, scientific and commercial projects
Assist with develop SOPs and ensure compliance with process & quality of deliverables within the development program
Support publication activities and scientific presentations
Maintain expertise in the field of biostatistics, and bring best practices and new methodologies in- house
Author or contribute to reports and/or scientific presentations and manuscripts
Perform statistical analysis, create summary tables, listings and figures in SAS and validate statistical analysis as defined in the analysis plan with oversight from supervisor
Prepare analyses that support regulatory submissions for product approval
Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and stakeholders
Perform sample size and power calculations
Assist in review of CRFs and edit checks; review and understand DM plans
Develop and maintain department tools, templates, guidelines, SOPs and systems
Work with Data Management partners to organize timely and accurate data extraction from EDC system into statistical programs for analysis
Qualifications:

PhD in Statistics/Biostatistics or related degreee with 2+ years’ experience in the device/pharma industry
Expert level use of Statistical software including SAS
Demonstrated ability to use of EDC/CTMS databases
Knowledge of applied statistics for the purposes of regulatory submissions, claims substantiation and peer-reviewed publications
Basic knowledge of Global Regulatory Requirements and Standards for statistical applications in the conduct of Clinical Research
Proven ability to initiate process improvements and work in a matrix environment where cross-functional interaction is required
Proven ability to deliver on delegated work efficiently
Good interpersonal, collaborative and communication skills required
Solid time management skills to meet deliverables commensurate with a fast-paced environment
Well organized, able to multitask and prioritize competing tasks
Able to manage expectations of supervisor, peers and customers