| Job Description | Description:
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, which is approved for the treatment of a rare inflammatory condition, Regeneron has completed Phase 3 clinical trials of rilonacept for a new indication and of product candidates EYLEA (aflibercept injection; VEGF Trap Eye) in diseases of the eye and ZALTRAP (aflibercept) (VEGF Trap) in colorectal cancer. EYLEA is currently under review with U.S. and European regulatory authorities. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis, pain, cholesterol reduction, allergic and immune conditions, and cancer.
The Sr. Biostatistician implements and executes methodological and statistical aspects of clinical studies with direction from Therapeutic Area lead biostatistician or project lead statistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases principal function could be to develop / employ technical expertise in a particular statistical area or application.
Key Responsibilities:
- Support/participate in the development of clinical program.
- Review protocols and CRFs for soundness of trial design.
- Write statistical methodology section of the protocol.
- Prepare analysis plan and programming specifications
- Perform inferential analyses; inputs to the statistical section
of the clinical study report and review clinical study report
- Support/participate in project related activities including
preparation of BLA submissions and oversee CRO deliverables for
studies contracted out.
Requirements:
- PhD and at least 2 years of biopharmaceutical experience or a MS
with at least 5 years of experience are required.
- The successful candidate will also possess strong statistical and
data analysis skills
- Strong knowledge of statistical and clinical trial methodology.
- Solid hands-on experience as statistician in clinical development
program.
- Good knowledge of drug development process, and experience in
supporting BLA submissions.
- Strong ability in protocol development, analyses and clinical
trial reports/publications of clinical trials.
- Excellent oral and written communication skills
- Knowledge of FDA/ICR guidelines; good knowledge of SAS, S-Plus
(or R) computer packages.
- Good project management skills are also required.
Responsibilities:
- With periodic supervision and guidance from senior departmental
staff, provide support and leadership to a clinical study team on
all relevant statistical matters.
- Act as liaison to study team, ensuring that the clinical study is
conducted in a manner that supports planned statistical analysis.
- With some supervision and guidance from senior departmental
staff, design clinical study and help produce protocol or
amendments. Perform relevant sample size calculations.
- Develop statistical analysis plan (SAP).
- Work with programming team to provide definitions, documentation,
and review of derived variables needed to produce planned TFL.
- Perform statistical analysis defined in SAP, prepare statistical
methods and results sections for the clinical study report (CSR),
and work with the study team to move the CSR through review and
approval process.
- Provide statistical insight into interpretation and discussion of
study results.
- Produce / coordinate production of statistical summaries,
analyses, annual reports, and related materials for submission to
regulatory authorities or independent monitoring committees.
- Provide assistance to project biostatistician or Therapeutic Area
lead biostatistician in project activity and timeline tracking,
resource planning, and preparation of scientific reports or
position papers.
Experience:
Technical Skills:
- SAS, S-Plus (or R), Sample size calculation software, and MS
Office.
Core Competencies:
- Must be able to work in a consistently busy environment
- Flexibility and multi-tasking are highly desirable skills for
this position.
- Written and oral communication Skills
- Research Experience a plus
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
EOE/M/F/D/V
Disclaimer: Effective immediately, Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex. |
| | Company | | Regeneron | Job Code | | State or Province | | New York | | |
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