Senior Manager, Biostatistics - Medical Affairs

Regeneron Pharmaceuticals•Sleepy Hollow, WY

7d•Onsite

About The Position

Regeneron is seeking a Senior Manager, Biostatistics - Medical Affairs to join our team! The Senior Manager of Biostatistics will be responsible for statistical support for Immunology within Medical Affairs and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including BDM, Medical Affairs/HEOR, Clinical Development, Regulatory Affairs and other functions as needed. In addition, the Senior Manager of Biostatistics will support collaborations with external partners (e.g. CROs, industry consortiums, key opinion leaders). They will work with the Medical Affairs Biostatistics therapeutic area lead for Information & Immunology to drive and establish best practices to support Immunology program continuous growth and Life Cycle Management (LCM) needs. In this role, a typical day might include: Interacts with Medical Affairs functional area colleagues including but not limited to Medical Directors, HEOR, Publications, Medical Information, Scientific Communication and other functional area colleagues like Clinical Scientists, Statistical Programming, Data Management, Medical Writing, and others for evidence generation efforts and HTA support including external collaborators. 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. To be involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. This role might be for you if you can/have: Strong interest and motivation in exploring existing clinical trial data for post-hoc analysis and innovative ideas investigations Experience with designing clinical trials especially observational types of studies, and Bayesian methods, machine learning techniques and causal inference methods Exposure to Dermatology/Respiratory study endpoints and analysis techniques Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences. Desire to present and share results with internal and external stakeholders and co-author publications, as well as present at statistical/medical congresses Experience with providing scientific/statistical input into study design, formulating novel problem-solving methods and independently developing the statistical analysis plan to implement those solutions. Experience of authoring Statistical Analysis Plans (SAP) and Protocols Experience with innovative ways to generate tables, listings, and figures for external communication use in publications/presentations and for internal purposes. Ability to translate and apply relevant innovative statistical methodology to everyday work. Experience of educating and disseminating knowledge throughout the organization for areas within the expertise of medical affairs.

Requirements

PhD or equivalent degree in statistics/biostatistics with >4 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >9 years’ experience.
Knowledge of drug life cycle management and strategies is preferred; knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies is a plus.
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.
Be able to prioritize with multiple priorities and thrive in multitask type of environment
Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
Ability to write code in statistical software (i.e. SAS, R, Python) is required.

Nice To Haves

Strong interest and motivation in exploring existing clinical trial data for post-hoc analysis and innovative ideas investigations
Experience with designing clinical trials especially observational types of studies, and Bayesian methods, machine learning techniques and causal inference methods
Exposure to Dermatology/Respiratory study endpoints and analysis techniques
Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences.
Desire to present and share results with internal and external stakeholders and co-author publications, as well as present at statistical/medical congresses
Experience with providing scientific/statistical input into study design, formulating novel problem-solving methods and independently developing the statistical analysis plan to implement those solutions.
Experience of authoring Statistical Analysis Plans (SAP) and Protocols
Experience with innovative ways to generate tables, listings, and figures for external communication use in publications/presentations and for internal purposes.
Ability to translate and apply relevant innovative statistical methodology to everyday work.
Experience of educating and disseminating knowledge throughout the organization for areas within the expertise of medical affairs.

Responsibilities

Interacts with Medical Affairs functional area colleagues including but not limited to Medical Directors, HEOR, Publications, Medical Information, Scientific Communication and other functional area colleagues like Clinical Scientists, Statistical Programming, Data Management, Medical Writing, and others for evidence generation efforts and HTA support including external collaborators.
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.
To be involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.

Benefits

comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

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