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This contractor position will support a Rare Disease program.

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.

In this role, a typical day might include:

• Supports design, execution and reporting of clinical trials, under the direct supervision of an experienced study statistician. Prepares mock tables/figures/listings (TFL) and works closely with the study statistician and the study statistical programmers to generate and review TFLs for clinical study reports, integrated summaries of safety (ISS), and integrated summaries of efficacy (ISE).
• Experience in statistical methods to support Health Economics and Outcomes Research including meta-analysis, patient reported outcomes (including development/validation), and/or HTA/reimbursement/value dossiers, and real world studies.
• Performs exploratory and ad hoc analyses of clinical trial data under the direction of the study statistician.
• Prepares TFLs to support DSUR and IB documents.
• Under the direction of the study statistician, coauthors statistical analysis plans and reviews data specs that support the statistical analyses.
• Collaborates with study team members to implement protocol deviation process
• Experienced candidates will coordinate departmental deliverables for DSUR and IB submissions, as well as assisting the lead project statistician on tracking timelines and deliverables for clinical studies.

Minimum Required Experience:

• PhD or equivalent degree in statistics/biostatistics or related fields or MS degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry as a statistician.
• Clinical trial experience in a biotechnology / pharmaceutical company or CRO is preferred.
• Proficient in SAS and/or R programming.
• Experience in a Biostatistics/Statistics function supporting Rare Disease is preferred
• Good oral and written communication skills.
• Experience/skills creating high-quality graphics is a plus.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation

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