Biostatistician

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.