Manager, Biostatistics - Hematology
- Regeneron Pharmaceuticals, Inc.
- Basking Ridge, New Jersey
- Start date
- Mar 7, 2023
- Science/R&D, Biostatistics
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Pharm Country, Best Places to Work
This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development.
As a Manager, Biostatistics, a typical day might include:
Working 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. You will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. You will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.
This role might be for you if you have experience:
Interacting with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.
Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting.
Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making.
Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.
Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.
To be considered for this opportunity, you must have the following:
PhD or equivalent degree in statistics/biostatistics with >2 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >6 years’ experience.
Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
Expertise in statistical software such as R or SAS is required
Salary Range (annually)$121,200.00 - $197,800.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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