Principal Biostatistician- REMOTE
Company: Precision For Medicine
Location: San Antonio
Posted on: January 15, 2022
This position provides statistical support for all phases of
clinical development. Specific responsibilities include reviewing
statistical sections of protocols, writing statistical analysis
plans, and developing SAS programs.
Essential functions of the job include but are not limited to:
Generate randomization schedules.
Provide sample size calculations.
Provide input into development of case report forms (CRFs).
Author statistical analysis plans, including development of table
and listing shells.
Review statistical analysis plans written by other
Generate analysis datasets, tables, figures, and listings to
support the analysis of clinical trials data using SAS.
Provide programming support to supplemental or exploratory analyses
for regulatory agencies or any other internal and external ad-hoc
Perform quality control for SAS programs and other study documents
(e.g., presentations and reports).
Provide statistical analysis and reports to Data Monitoring
Review output across programs to ensure consistency.
Prepare statistical sections of clinical study reports.
MS or degree in Statistics and a minimum of 10 years of relevant
Knowledge of industry standards, such as the ICH guidelines, CDISC
data structures, 21 CFR Part 11, and FDA guidelines.
Experience with SAS.
Experience with oncology and rare disease.
Experience with submissions.
Excellent organizational skills, time management, and ability to
coordinate workload and meet established deadlines.
Excellent communication and interpersonal skills to effectively
interface with others
Excellent problem solving skills.
Excellent presentation skills.
Sound judgement/decision making.
Ability to establish and maintain effective working relationships
with coworkers, managers and clients.
Any data provided as a part of this application will be stored in
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
Keywords: Precision For Medicine, San Antonio , Principal Biostatistician- REMOTE, Other , San Antonio, Texas
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