Senior
Biostatistician
General Job Description: Will be responsible for
planning, analyzing, reviewing, interpreting, and summarizing the statistical
component of clinical and nonclinical research projects in compliance with
regulatory guidelines and requirements in support of INDs and NDAs.
Core Responsibilities:
- Participate in one or more project teams as
biostatistician/lead biostatistician.
- Provide preclinical and clinical statistical support
requirements of the company including experimental designs, statistical
analyses, power calculations for sample size determination, and
formulation of statistical analysis sections of protocols,
clinical/nonclinical study reports, and regulatory submissions.
- Review Case Report Forms (CRF) to ensure all relevant data
necessary for data analysis is captured.
- Select appropriate best-practices randomization and
stratification methods for study design.
- Provide other statistical support services as needed
(e.g., interim analysis strategies in line with regulatory guidelines for
study size and power calculation adjustments; DSMB participation; NDA and
other submissions to regulatory agencies).
- Develop statistical analysis plans, analyze clinical study
data using SAS, verify quality of final tables, listings and graphs produced
by SAS programmers, write statistical reports, and contribute to authoring
clinical/statistical reports, interpreting results and writing statistical
sections as needed.
- Must be able to work both independently and as effective
team player across disciplines with the Clinical and Nonclinical Groups.
- Demonstrated experience in experimental designs, general
linear models, categorical data analysis, survival analysis, analysis of
repeated measures, and multiple testing adjustments.
- Programming experience in SAS is required.
- Oncology experience is desirable.
Qualifications:
- Ph.D. in Biostatistics or Statistics required. At least 3
years of Clinical Pharmaceutical Industry Experience and Oncology
experience desirable.
In addition to a competitive
salary and benefits package, BioNumerik offers a technologically innovative and
intellectually stimulating, team-oriented work environment, as well as an
excellent opportunity for professional growth. If you are interested in joining
the BioNumerik team, please forward your resume to: BioNumerik Pharmaceuticals,
Inc., Attn: HR, 8122 Datapoint Drive # 1250, San Antonio, TX 78229 or resume@bnpi.com.