Sr. Biostatistician (contractor)
Company: AnaptysBio, Inc.
Location: San Diego
Posted on: March 28, 2020
Position SummaryThe Senior Biostatistician will participate in
designing clinical studies, assist in protocol development, review
study protocols, contribute to and review data management
documents, oversee statistical analysis activities, create and/or
review statistical analysis documents, SAPs, assist in CSR
development and/or review CSR, contribute to Data Management Plans.
This role may also participate supporting analysis of non-clinical
/ pre-clinical /CMC data when needed. Expected to work closely with
Clinical Study Team members and with Dir, Data Management. Expected
to direct and oversee statistical analysis deliverables from
- Demonstrate practical understanding and recognition of
statistical concepts and methodologies appropriate for use in the
pharmaceutical industry. Provide statistical support for design,
analysis, and reporting of clinical, nonclinical or pharmacokinetic
- Ensure internal consistency and assess consistency with other
studies, if applicable, and provide certification for the protocol
review check list. Develop statistical methods sections for routine
studies and, with supervision, for non-routine studies, and ensure
alignment with analyses as conducted.
- Contribute to decision making on study design and data
collection, and, with supervision, ensure appropriateness to
support study objectives. Work collaboratively with others to
develop quality protocols, CRFs, databases, reports, and
publications per agreed timelines.
- Responsible for sample size calculations for routine studies.
Calculate sample size for non-routine studies with
- Determine statistical methods for routine studies, and ensure
statistical methods adequately address study objectives. Able to
apply statistical knowledge to solve drug development problems.
Identify and recommend corrections for flaws in scientific logic
and statistical interpretation.
- Contribute to statistical methodology for non-routine studies.
Provide statistical insight into the development of report strategy
and assist in ensuring consistency among reports within a
- Ensure clarity, accuracy and consistency of case report forms
(CRFs), database definitions, and specifications for analysis data
sets for individual studies. Develop statistical analysis plans
(SAPs) for routine studies and, with supervision, for non-routine
studies, ensure consistency.
- Provide accurate and timely responses to routine requests from
clients and independently pursue analyses suggested by the data.
Responsible for developing and maintaining good client
relationships. Identify and report on data issues or violation of
statistical assumptions that could affect the validity or
sensitivity of planned analyses. Recommend alternative analysis
strategies to address data issues or violation of statistical
- Assist development of project conventions and verify project
conventions are followed.
- Ensure accuracy of database quality assurance checks and assess
data accuracy and consistency. Develop database checks for routine
- Participates in the preparation of data review and regulatory
- Writes or reviews key study documents to ensure optimal
statistical presentation and compliance. These documents include,
but are not limited to, protocols, analysis plans, tables,
listings, and figure (TLF) specifications, study reports.
- Ensures efficient planning, execution and reporting of clinical
studies and statistical review of critical documents such as CRFs,
Data Validation Plans, CDISC, SDTM/ADaM data specifications,
- Ensures statistical analyses performed in accordance with the
protocol, statistical analysis plan, good statistical practice, and
available regulatory guidelines.
- Developing Statistical Protocols: Effectively communicates with
project manager to understand to objectives of the study. Follows
the appropriate operating procedure required for developing the
statistical plan. Demonstrates the ability to research and provide
appropriate statistical input to the study design.
- Data Analysis: Write SAS code for common statistical analyses.
Understands and correctly uses validated SAS macros in the data
analysis programs. Understands program verification procedure;
writes and executes program verification plans.
- Post-Analysis Activities: Participates in the creation of the
verification plan and line listings. Prepares and reviews
statistical sections contained in submissions and other
publications. Prepares statistical summaries in a timely manner for
team and management review.
- Provide in-depth statistical expertise in the areas of;
experiment, protocol, case report form design, data base structure,
and analysis plan; collaborate with the medical groups to complete
joint scientific reports and FDA overviews, including review of
such reports to ensure accuracy and clarity.RequirementsEducation &
- Theoretical knowledge typically achieved through a related
post-graduate college experience, such as a PhD degree in
Statistics or a related field.
- Five/Eight years of statistics experience in the pharmaceutical
or related industry.
Keywords: AnaptysBio, Inc., San Diego , Sr. Biostatistician (contractor), Other , San Diego, California
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