Senior Scientist, Biostatistics
- 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.
- 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.
- 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.
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.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
10/27/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R409817
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