Title: Biostatistician II
Company: Medical Device
Location: Minneapolis, MN
Type: Permanent Role
Notes: No Corp to Corp
- Responsible for understanding regulatory (or other audience) requirements for scientific validity of studies.
- Responsible for understanding and responding to client comfort with statistical risk regarding design and size of study.
- Identifies and documents measurable study objectives.
- Develops and documents a design for the study, including determining the sample size necessary to guarantee with high probability that the study will be able to meet its objectives.
- Develops and documents an analysis plan for studies ensuring that they meet FDA guidelines.
- Performs statistical analyses and provides statistical expertise and support to clients and internal project team members.
- Documents the results and interpretation of analyses.
- Prepares and delivers presentations on statistical methodology or applications at conferences or for courses; authors blogs and whitepapers.
- Develops and documents comparative study-design strategies based on regulatory, scientific, financial, and other risks and considerations.
- Presents, discusses, and defends designs and analysis to decision-makers (e.g. IRBs, NBs, FDA, CMS, etc.).
- Identifies and develops new statistical methods, software, etc. for use.
- Responsible for orally communicating study results and interpretations to client when necessary.
- Provides consultation to clients on statistical matters.
- Master of Science degree in Statistics, Biostatistics, Math, or Epidemiology.
- PhD preferred.
- Three to five years of experience in study design and data analysis or equivalent education.
- A minimum of three years of experience with SAS, SPSS, BMDP, or other programming-oriented statistical analysis software.
- Excellent oral communication and interpersonal skills.
- Excellent technical writing skills.
- Strong organizational skills and detail orientation.
- Ability to travel.
- Strong working knowledge of Microsoft Access, Excel, Word, and PowerPoint preferred.