The Senior Biostatistician provides statistical input into Phase I – IV clinical trial development. Responsibilities include statistical input into protocol development (e.g., trial design, sample size estimation, randomization, statistical methods for protocols); developing statistical analysis plans (SAPs) and mock tables listing and figures (TLFs), statistical analysis, and writing detailed statistical analysis plans including specifications for analysis files.

DUTIES AND RESPONSIBILITIES:

  • Develops SAPs and mock TLFs
  • Analyzes clinical trial data, validates statistical output, accurately interprets, and clearly communicates statistical results and concepts to non-statisticians
  • Ensures the high quality of all services and deliverables provided by Statistics at MedSource
  • Collaborates effectively with members of clinical trial teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance
  • Supports MedSource Clinical and Biometric Project Managers to ensure the timely, accurate and appropriate processing of clinical trial data to support clinical trial reporting
  • Supports MedSource Clinical and Biometric PMs with the use of SAS and assist with tasks such as database reconciliation and validation as necessary using SAS programming

MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:

  • MS and/or PhD degree in Statistics or Biostatistics or related field
  • Understanding of statistical concepts and techniques
  • Expertise in SAS
  • Knowledge of CDISC standards, including SDTM and ADaM datasets
  • Excellent communication skills
  • Fluent in English
  • Basic familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
  • A minimum of 2 years’ experience in CRO or Biopharmaceutical environment

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Expert SAS skills
  • Statistical knowledge and an understanding of the principles of Data Management
  • Customer focus and ability to see things from customer’s perspective
  • Good organizational and planning skills with the ability to be flexible and adapt to change
  • Ability to manage multiple projects at one time, under tight deadlines, providing attention to detail
  • Ability to prioritize tasks and resources
  • Good problem solving and effective decision making
  • Effective written and verbal communication

CONDITIONS OF EMPLOYMENT:

Verification   of    educational   requirements,   employment   history,   professional  references,   and certifications/training.

WORKING CONDITIONS AND PHYSICAL EFFORT:

  • Work is normally performed in a typical interior/office work environment
  • Minimal travel may be required

MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

 

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