Senior Scientist, Biostatistics

Senior Scientist, Biostatistics – Rahway, NJ: 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: Must have a 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. Required Experience and Skills: Must also possess knowledge of statistical analysis methodologies and experimental design; and working knowledge of statistical and data processing software e.g. SAS and/or R. Good oral and written communication skills and ability to work effectively with personnel with different functional background required. Must demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development; and possess the ability to learn, be proactive and motivated, and consistently focus on details and execution. The salary range for this role is: $117,000.00 - $184,200.00 per year This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.   The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.   We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S.