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Job: Senior Biostatistician

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Posted: 04/17/2017

Job Status: Full Time

Job Description

Directs departmental activities and maintains the statistical integrity of clinical trials analyzed by SDC. Leads efforts in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.

Primary Responsibilities:

  • Act as the lead statistician on clinical research projects
  • Provide statistical expertise for study design of clinical trial protocols
  • Write statistical methods section of the study protocol, as needed
  • Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
  • Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol
  • Program summary tables, data listings and graphical representations of clinical trials data
  • Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
  • Prepare key sections of clinical study reports and various regulatory documents
  • Perform statistical QC of final clinical study reports
  • Provide statistical support to answer questions from external clients (such as FDA, Investigators)
  • Contribute to the development of standard operating procedures for clinical trials
  • Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
  • Adhere to all aspects of the SDC's quality system
  • Comply with SDC's data integrity & business ethics requirements
  • Perform other related duties incidental to the work described herein

Skills / Requirements

Required Skills:

  • Excellent analytical skills, with the ability to process scientific and medical data
  • Able to work independently
  • Excellent knowledge of statistical programming
  • Expertise in manipulating and analyzing SAS data
  • Ability to identify data issues, present problems, and implement solutions.
  • Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
  • Good leadership, organizational and time management skills, with the ability to multi-task
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
  • Strong interpersonal communication and presentation skills
  • Ability to effectively collaborative across cross-functional teams

Education or Equivalent Experience:

  • Master's degree in biostatistics, statistics or other related, scientific field and four years of clinical trials experience. A PhD in biostatistics, statistics, or other related, scientific field is preferred.

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jobs@sdcclinical.com
480-632-5468 EXT. 200

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Tempe, AZ 85281

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