Biostatistician




JOB ROLE: The Biostatistician determines analysis and data presentation specifications for programmer analysts; performs analysis, interprets study results, and collaborates with medical and biostatistics staff to produce interim reports and final reports, ensuring that the biostatistics portion of project timelines are met with superior quality deliverables



PRINCIPAL RESPONSIBILITIES include:

· Collaborating with program staff on the implementation and analysis of Biostatistics aspects of research protocols.

· Providing statistical consultation for clinical programs, including but not limited to randomization, sample size assessments, efficacy evaluations, and data review.

· Participating in eCRFs design and the corresponding edit checks to ensure that protocol objectives are met and project standards are maintained.

· Developing clinical data file (CDF) specifications, and specifications for any other data transfers.

· Writing CDF test data specifications, and coordinating the data entry effort.

· Coordinating with SAS programming staff to ensure the accurate programming of CDF extracts and data displays.

· Developing statistical analysis summary and analysis plans.

· Developing programming specifications to summarize the results of clinical trials.

· Performing statistical analyses.

· Providing tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.

· Providing content expertise and writing selected sections of project final reports.

· Developing report and programming specifications, and coordinating programming and testing.

· Writing or coordinating the development of test data specifications, and coordinating data entry effort



QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:

· BS in Life Sciences and 7 years related experience.

· Or MS in Mathematics or Biostatistics with 5 years related experience.

· Or doctorate-level degree in Statistics or Biostatistics with 2 year related experience.

· Data handling or analysis experience required.

· Knowledge of the biostatistical, programming, and data management aspects of the clinical research service industry.

· Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.

· Experience with the management and statistical analysis of data obtained from Phase I - IV clinical trials.

· The ability to synthesize results in graphic, oral, and written reports.

· Experience using SAS (including data manipulation) and other software packages such as SPSS, S-Plus.



PERSONAL SKILLS & ATTRIBUTES:

· Excellent interpersonal and organization skills, highly detail-oriented.

· Good oral & written communication skills.

· Willingness to learn new programming languages, new technology, and new tools.