Biostatistician I - Rare Disease Clinical Trials

Clinical Solutions, San Diego, California

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Date Posted January 11, 2021
Industry Private Sector BioStat Jobs
Specialty Not Specified
Job Status Not Specified
Salary Not Specified


Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Position Summary:
Provide statistical support for all phases of clinical development. Specific responsibilities include writing statistical analysis plans under close supervision of senior statisticians, and developing SAS programs

Essential functions of the job include but are not limited to:

Generate randomization schedules under close supervision of senior statisticians
Assist with statistical methods review of the clinical study protocol under close supervision of senior statisticians
Assist with sample size calculations
Assist with review of case report forms (CRFs).
Author statistical analysis plans, including development of table and listing shells under close supervision of senior statisticians
Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports).
Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
Assist with statistical consulting tasks
Assist with output review across programs to ensure consistency.
Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician under close supervision of senior statisticians
Review statistical sections of clinical study reports under close supervision of senior statisticians
Work directly with sponsors, project managers, and external vendors on statistics-related project components under close supervision of senior statisticians
Interact directly with clients under close supervision of senior statisticians

Minimum Required:
MS degree or equivalent in statistics, biostatistics, mathematics

Other Required:
Experience with SAS

Understanding of statistical concepts and techniques, such as inference, analysis of variance, linear models, regression, survival analysis, non-parametric analysis, estimation, hypothesis testing, and statistical modeling
Familiarity with clinical trial concepts, such as randomization, hypothesis testing, estimation of treatment effects, sample size calculation, etc.
Ability to program basic data presentations (e.g. with SAS procedures MEANS, FREQ, UNIVARIATE, PLOT /GPLOT and the DATA step) and common statistical analyses (e.g. with SAS procedures GLM, MIXED, and LIFETEST)
Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
Excellent communication and interpersonal skills to effectively interface with others.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
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