Key Responsibilities:
- Statistical Support:Provide statistical support to clinical studies.
- Data Review:Review analysis datasets and efficacy tables, listings, and figures (TLFs).
- Statistical Analysis:Perform statistical analyses and interpret results.
- Report Preparation:Prepare clinical study reports, including integrated summaries for submissions.
- Communication:Present and explain methodology and the consequences of decisions in lay terms.
- Team Collaboration:Serve as a team player, showing adaptability and flexibility when priorities change, and going the extra distance to achieve results and meet deadlines.
Required Knowledge, Skills, and Abilities:
- Communication Skills:Excellent written and oral communication skills, including grammatical/technical writing skills.
- Attention to Detail:Excellent attention to detail and accuracy.
- Regulatory Knowledge:In-depth knowledge of applicable clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Statistical Methods:Familiarity with moderately complex statistical methods applicable to clinical trials.
- Individual Initiative:Strong initiative and ability to work independently.
- Organizational Skills:Strong organizing skills and ability to manage multiple tasks and projects effectively.
- Technical Proficiency:Strong working knowledge of the SAS computing package and familiarity with other relevant statistical computing packages.
- Quality Commitment:Strong commitment to quality.
- Team Leadership:Ability to lead and coordinate small teams.
- Problem Solving:Ability to solve moderately complex problems.
- Data Standards:Working knowledge of relevant Data Standards (e.g., CDISC/ADaM).
Minimum Required Education and Experience:
- PhD in Biostatisticsor related field with 1 year of relevant experience.
- Masters Degree in Biostatisticsor related field with 3 years of relevant experience.
- Bachelors Degree in Biostatisticsor related field with 5 years of relevant experience.
- Equivalent Combination:Equivalent combination of education, training, and experience may be considered.
