Statistician

BioStat Solutions, Inc. - Frederick, MD

Full-timeEstimated: $83,000 - $110,000 a year
EducationSkills

Job Objective:

Statistician in support of design, analysis and interpretation of complex data at BSSI

Details:

  • Perform statistical analysis and programming (SAS, R and other appropriate languages such as Python)
  • Design, analyze and interpret drug biologic and device studies for regulatory approval
  • Independent project development, including but not limited to, ascertainment of client needs, recommendations on statistical methodology, and authoring Statistical Analysis Plans (SAPs)
  • Critically evaluate optimum analytical methodology for individual projects
  • Report findings in Statistical Analysis Reports, executive summaries and slide presentations
  • Interact with clients through emails, conference calls and on-site visits
  • Support BSSI’s Business Development efforts through delivery of superior work product and effective communication with clients and team members
  • Consider effect of biomarkers in stratification of disease, response and patient populations
  • Provide analysis, quality control and validation for manufacturing studies
  • Conduct work in accordance with BSSI standard operating procedures (SOPs), BSSI QA/QC policies, client-specific requirements and applicable regulatory guidelines
  • Validate statistical results with team members to ensure high quality deliverables
  • Provide technical writing for analysis plans, protocols and regulatory documents as needed, and summarize results (i.e. tables, figures and listings) for inclusion in presentations or reports
  • Provide guidance to staff with respect to statistical methodology and programming
  • Participate in internal research and development activities

Qualifications:

  • Ph.D. or M.S. with at least three years of pharmaceutical experience with preferred Degree in Biostatistics
  • At least 3-5 years of industry specific work experience
  • Proven experience with CDISC, SDTM and ADaM specifications
  • Demonstrated leadership ability
  • Excellent communications skills
  • Demonstrated writing ability in English
  • Proficiency in SAS and R
  • Proven ability to work independently and in a team environment
  • Excellent analytical and problem-solving skills
  • Efficient time management
  • Qualified candidates must be legally authorized to be employed in the US

BioStat Solutions, Inc. is a voluntary equal opportunity employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire

HR-OP-ST-SAC-002 09/26/2018

Job Type: Full-time

Experience:

  • Work: 2 years (Preferred)
  • R: 2 years (Preferred)
  • SAS: 2 years (Preferred)

Education:

  • Master's (Required)

Work authorization:

  • United States (Required)