Senior Scientist, Biostatistics

MSD • North Wales, PA

3d • $117,000 - $184,200 • Hybrid

About The Position

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. Responsibilities: 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.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior