Senior Scientist, Biostatistics

MSD • Rahway, NJ

13h • Onsite

About The Position

Serve as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting. Develop individual protocols and data analysis plans and determine appropriate statistical methodology for data analysis. Participate in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. Collaborate with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Evaluate appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex techniques to these analyses. Prepare oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators. Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Be responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies. Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies. Be involved in research activities for innovative statistical methods and applications in clinical trial development.

Requirements

• Ph.D. in Statistics, Biostatistics, or related field OR a Master’s degree in Statistics, Biostatistics, or related field 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.
• Ability to work effectively with personnel from different functional backgrounds.
• Strong interest in statistical research activities and application of novel methods to clinical trial development.
• Ability to learn, be proactive and motivated.
• Consistently focus on details and execution.

Responsibilities

• Serve as statistical representative in cross-functional teams for clinical trial planning, execution, and reporting.
• Develop individual protocols and data analysis plans.
• Determine appropriate statistical methodology for data analysis.
• Participate in database design meetings to ensure data quality and analysis satisfaction.
• Collaborate with statistical programming staff to ensure programs meet requirements.
• Evaluate software appropriateness for planned analyses and identify needs for program development.
• Analyze data and interpret results from clinical trials.
• Independently apply and implement basic and complex analytical techniques.
• Prepare oral and written reports to communicate clinical trial results.
• Provide responses to queries regarding study design, analysis, and interpretation.
• Plan and ensure accuracy of Statistical Review Aids for regulatory agencies.
• Participate in discussions with regulatory agencies and investigators concerning studies.
• Engage 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
• Annual bonus
• Long-term incentive

What This Job Offers

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