Scientist, Stat. Programming - Late-Stage (Non-Oncology) (Hybrid)

Planning Research Marketing Management Innovation Statistics Compassion Coordinating Data Science Communication Data Analysis Biostatistics SAS (Software) Drug Discovery Clinical Trials Data Management Data Processing Team Management Database Design Telephone Skills Decision Science Numerical Analysis Statistical Methods Experimental Design Program Development Scientific Modeling Statistical Analysis Contingent Workforce Statistical Research Clinical Study Design Statistical Programming Clinical Trial Planning Research And Development R (Programming Language) Clinical Trial Development Standard Operating Procedure, In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health., * Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists part of our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• The incumbent may initially work in a specific disease therapeutic area.

Primary activities :

• Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
• Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development, Marketing Leadership Innovation Statistics Compassion SAS Macros Forecasting Data Analysis Life Sciences Biostatistics Data Modeling Collaboration Accountability SAS (Software) Clinical Trials Data Management Project Planning Computer Science Telephone Skills Decision Science Microsoft Project Outcomes Research Project Management Numerical Analysis Process Improvement Applied Mathematics Program Development Reporting Processes Project Stakeholders Statistical Analysis Contingent Workforce Statistical Modeling Electronic Submission Waterfall Methodology Statistical Programming Relationship Management Research And Development Pre-Clinical Development Clinical Data Management R (Programming Language) Stakeholder Requirements Interpersonal Communications Product Lifecycle Management Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle Clinical Data Interchange Standards Consortium +0 Associate Principal Biostatistician Clinical Safety Statistics (CSS) Merck & Co., Inc

North Wales, PA*On-Site

Writing Planning Research Marketing Leadership Management Innovation Statistics Compassion Epidemiology Communication Presentations Biostatistics SAS (Software) Drug Discovery Clinical Trials Risk Management Data Processing Disease Biology Safety Standards Drug Development Telephone Skills Decision Science Clinical Research Survival Analysis Shiny (R Package) Project Management Strategic Planning Bayesian Inference Statistical Methods Scientific Modeling Statistical Analysis Regulatory Documents Contingent Workforce Willingness To Learn Statistical Research Statistical Graphics Regulatory Compliance Clinical Study Design Artificial Intelligence Regulatory Requirements Research And Development Pre-Clinical Development R (Programming Language) Standard Operating Procedure Active Directory Application Mode Non-Disclosure Agreement (Intellectual Property Law) +0 Sr. Scientist, Stat. Programming - Late-Stage (Non-Oncology) (Hybrid) Merck & Co., Inc

North Wales, PA*Hybrid

Research Marketing Leadership Innovation Statistics Compassion SAS Macros Forecasting Data Analysis Life Sciences Biostatistics Data Modeling Collaboration Accountability SAS (Software) Clinical Trials Data Management Project Planning Computer Science Telephone Skills Decision Science Microsoft Project Outcomes Research Project Management Numerical Analysis Process Improvement Applied Mathematics Program Development Reporting Processes Project Stakeholders Statistical Analysis Contingent Workforce Statistical Modeling Electronic Submission Waterfall Methodology Statistical Programming Relationship Management Research And Development Pre-Clinical Development Clinical Data Management R (Programming Language) Stakeholder Requirements Interpersonal Communications Product Lifecycle Management Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle Clinical Data Interchange Standards Consortium +0 Login | JoinContact

PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master's degree with a minimum of 3 years relevant experience., * Knowledge of statistical analysis methodologies and experimental design.

• Working knowledge of statistical and data processing software e.g. SAS and/or R.
• Good oral and written communication skills. Able to work effectively with personnel with different functional background.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience :

• An understanding of biology of disease and drug discovery and development.

BARDS2020

#eligibleforERP, Data Management, Data Science, Numerical Analysis, Scientific Modeling, Statistical Analysis, Statistical Research, Statistics

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.