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 Biostatistics or related field with 1 year of relevant experience.
Masters Degree in Biostatistics or related field with 3 years of relevant experience.
Bachelors Degree in Biostatistics or related field with 5 years of relevant experience.
Equivalent Combination: Equivalent combination of education, training, and experience may be considered.

Biostatistician