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Title:Contract Biostatistician
Salary:Open
Experience:3+
Location:MA - Cambridge

Description:
To provide dedicated statistical expertise and input for the design and analysis of clinical studies in support of PHASE IIIb/IV trials being sponsored by US Medical Affairs.

Responsibilities:
  • Guiding Medical Affairs in the statistical aspects of major projects.
  • Reviewing study concepts and providing advice on the design of studies.
  • Writing and/or reviewing statistical methods sections for Phase IIIb/IV study protocols, integrated study reports and publications.
  • Writing statistical analysis plans for Phase IIIb/IV studies, as well as for integrated safety and efficacy summaries.
  • Preparing suitable randomization (for randomized studies) for Phase IIIb/IV studies.
  • Reviewing and commenting on proposed CRFs and data validation plans by working with Data Management.
  • Performing statistical analysis for Phase IIIb/IV studies and manuscripts.
  • Reviewing manuscripts for accurate statistics and statistical interpretation.
  • Keeping informed of major relevant developments in statistical, pharmaceutical and computing methodologies.
  • Validating tables and derived listings.
  • Acting as the statistical primary contact with CROs for studies that are outsourced.
  • Participating in statistical interactions with Regulatory Agencies.

Requirements:
  • Ph.D. in Biostatistics and/or Mathematics, or MS. with superior experience
  • At least 3 years experience in statistical issues for the pharmaceutical industry
  • Working SAS knowledge and proficient in SAS statistical procedures
  • Excellent oral and written skills in English
  • Minimum 3 years in a similar or related position
  • Extensive knowledge of, and with limited direction, application of routine statistical methodology
  • Fundamental knowledge of, and with direction, application of complex statistical methodology
  • Familiarization with relevant clinical areas
  • Applicable knowledge of ICH statistical and clinical report guidelines
  • Good computer skills including knowledge of SAS, Word, PowerPoint, MS Project, Excel and Lotus notes
  • Strong problem solver and critical thinker
  • Ability to communicate effectively with Senior Management
  • Ability to work within timelines and ensuring deadlines are met
  • Excellent time management and multi-tasking skills
  • Excellent written and verbal skills
  • Detail-oriented
  • Works well with a team
  • Highly self-motivated and reliable
  • Proactive and able to work independently
  • Normal and routine office duties

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