Associate Principal Scientist, Biostatistics
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
- Develops, coordinates, and provides statistical leadership and support for related drug/vaccine projects in Biometrics Research.
- Ensures that sound scientific principles and statistical methods are applied to designing and analyzing non-clinical and clinical studies in support of discovery and worldwide regulatory submissions.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories in coordinating the statistical activities for clinical drug/vaccine projects. May interact with Contract Research Organization (CRO).
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product discovery and development.
- Is involved in non-clinical or clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of non-clinical or clinical studies, proposes solutions and carries them out.
- Independently identifies opportunities to add value to drug/vaccine discovery and development programs.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for 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 non-clinical or clinical studies to meet program objectives. Independently applies and implements basic and complex statistical techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of non-clinical or clinical studies to the project team, Merck Management, regulatory agencies, or individual investigators.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the scientists, clinical monitors, regulatory agencies, and/or other investigators.
- 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 or drug development.
- Mentors and guides junior staff in functional activities
Education Minimum Requirement:
- Ph.D or equivalent degree in Statistics / Biostatistics or related discipline with a minimum of 3 years of relevant work experience OR a Master’s Degree with a minimum of 6 years relevant work experience. Relevant industrial experience is preferred
Required Experience and Skills:
- Experience with machine learning methods applied to analysis of very large data generated by high-throughput life science technology such as, for example, NGS, Proteomics, Flow Cytometry, Imaging, or High-Throughput screening.
- Excellent computer skills. Advanced R-programming experience. Knowledge of C, C++, Python, Matlab, SAS in Windows and Unix/Lunix environment.
- Strong interest in statistical research and application of novel methods demonstrated by publication record
- Ability to learn, be proactive and motivated, and consistently focus on details and execution.
- Ability to function effectively in a team environment
- Ability to collaborate with multi-discipline scientists
Preferred Experience and Skills:
- Bioinformatics, Cheminformatics, Signal or Image processing
- Assay development and validation (e.g., PCR, immunoassays, immunohistochemistry)
- Knowledge of technology platforms, e.g. NGS
- Application of Bayesian methods to high-dimensional-data analysis
- Graphical Models
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: None
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark