Job Openings

Senior Biostatistician Position

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.

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