Senior Biostatistician I - Clinical Trials (Remote, US)
Posted on: June 12, 2021
Job Title: Senior Biostatistician I
Job Location: Philadelphia, PA (Remote) or any US Remote
Provides biostatistical services to meet the requirements of all
Clinipace' s clients, including full-service, Global Clinical
Analytics (GCA), and other type studies. This may include but it's
not limited to: development and approval of Statistical Analysis
Plans and table shells, randomization schemes, review of data
management documentation, lead development of Protocols and approve
the statistical section in Clinical Study Reports, serve as Quality
Control Biostatistician or IDMC statistician.
Job Duties and Responsibilities:
Meets all the job duties, responsibilities, and requirements of
a Biostatistician in addition to those listed here.
- Coordinate and approve Statistical Analysis Plans (SAP),
mock-up tables, programming and derived dataset specifications
developed by Biostatistics and Statistical Programming staff.
- Lead protocol development work including experimental design,
randomization, sample size calculation, statistical methods,
defining study objectives and parameters.
- Coordinate and approve the statistical section of the Clinical
Study Report (CSR) written by Biostatistics staff and collaborate
with Medical Writer in preparing the integrated CSR as needed.
- Coordinate and approve TFL and derived datasets, programming of
derived datasets and Tables, Figures and Listings (TFL), and data
review and statistical analysis developed by Biostatistics and
Statistical Programming staff.
- Provide management of other Biostatistics Department
requirements and functions, such as SOP updates, as requested by
- Serve as Quality Control Biostatistician for sample size
- Serve as IDMC / DSMB statistician as needed.
- Other duties commensurate with the position as assigned by line
- Provide staff training and study oversight as requested by line
- Provide staff oversight as mutually agreed with line
No supervisory responsibilities.
The company will not accept unsolicited resumes from third party
vendors. Clinipace does not offer sponsorship for this role at this
Keywords: Clinipace, Austin , Senior Biostatistician I - Clinical Trials (Remote, US), Other , Austin, Texas
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