Senior Scientist, Biostatistics, Late Development Statistics
- Spring House, PA
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.
- Develops, coordinates, and provides biostatistical support for projects under supervision in Late Development Statistics.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug projects.
- Serves as a statistical representative in the cross-functional teams for clinical trial planning, execution, and reporting.
- Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data 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 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 techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, 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.
- 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.
- Is involved in research activities for innovative statistical methods and applications in clinical trial development
Education Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master's degree with a minimum of 3 years of relevant experience.
Required Experience and Skills:
- 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. Able to work effectively with personnel with different functional backgrounds.
- Demonstrate a 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 Experience and Skills:
- An understanding of the biology of disease, clinical trials and drug development.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And 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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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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