Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.
- Serves as a statistical lead in project teams.
- Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our other Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
The incumbent may initially work in a specific disease area (Oncology).
- Serves as a statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Is involved in 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 clinical trials, proposes solutions and carries them out.
- 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.
- May lead a team of statisticians and 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 the needs for potential program development of novel statistical methodology.
- Analyzes data and interpret results from clinical trials to meet the objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, company 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.
- May represent biostatistics in regulatory interactions including a presentation at advisory committee meetings
- 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.
- Mentors and guides junior staff in functional activities.
Education & Skills
Education and Minimum Requirement:
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years of relevant work experience, or a Master’s degree with a minimum of 9 years of relevant work experience.
Required Skills and Experience:
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Strong oral and written communication skills. Able to function effectively in a team environment.
- Demonstrate strong interest in statistical research activities and in the 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.
Preferred Skills and Experience:
- Publications in peer-reviewed statistical/medical journals.
- An understanding of the biology of disease and drug discovery and development.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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