
Senior Scientist, CMC Statistics
Are you looking for a challenging and rewarding career opportunity in the pharmaceutical industry? Merck & Co. is seeking a highly skilled and experienced Senior Scientist, CMC Statistics to join our dynamic team. As a global leader in healthcare innovation, we are committed to making a difference in the lives of patients around the world. In this role, you will utilize your strong statistical knowledge and expertise to support the development and manufacturing of life-changing medicines. If you possess a strong attention to detail, excellent problem-solving skills, and a passion for driving scientific innovation, then we encourage you to apply for this exciting opportunity. Join us and be a part of our mission to discover, develop, and deliver innovative healthcare solutions.
- Conduct statistical analyses and provide technical expertise to support CMC (Chemistry, Manufacturing, and Controls) biopharmaceutical development and manufacturing processes.
- Collaborate with cross-functional teams to design and implement statistical strategies for product development and process optimization.
- Develop and validate statistical methods and models to support process monitoring, control, and optimization.
- Conduct statistical analysis of data generated from laboratory experiments, clinical trials, and manufacturing processes.
- Interpret and communicate statistical results to non-technical stakeholders, including management and regulatory agencies.
- Stay updated on industry trends and best practices in statistical methodologies and apply them to support drug development and manufacturing.
- Generate and maintain statistical reports and documentation in compliance with regulatory requirements.
- Lead and provide guidance on statistical study design, sample size determination, and data analysis plans.
- Identify and troubleshoot statistical issues and propose solutions to improve product quality and process efficiency.
- Mentor and train junior team members on statistical concepts and techniques.
- Collaborate with external partners and vendors to ensure high-quality statistical support for projects.
- Adhere to company policies, procedures, and ethical standards in all work activities.
- Participate in scientific conferences and represent the company as a subject matter expert in statistical methodologies.
- Support regulatory submissions by providing statistical analyses and documentation.
- Contribute to continuous improvement initiatives to enhance the effectiveness and efficiency of statistical support for drug development and manufacturing processes.
Advanced Degree In Statistics, Biostatistics, Or A Related Field
Minimum Of 8-10 Years Of Experience In Pharmaceutical Or Biotech Industry, Specifically In Cmc (Chemistry, Manufacturing, And Controls) Statistics
Expertise In Statistical Methodologies For Process Development, Validation, And Control In Drug Development
Strong Understanding Of Regulatory Requirements And Guidelines For Cmc Statistics, Including Ich And Fda Guidelines
Proven Track Record Of Effectively Leading And Collaborating With Cross-Functional Teams To Drive Successful Drug Development Projects.
Project Management
statistical analysis
Problem Solving
Data Management
Technical Writing
Quality Control
Experimental design
Statistical modeling
Regulatory compliance
Interdisciplinary Collaboration
Statistical Reporting
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Scientist, CMC Statistics in Rahway, NJ 07065, USA is $130,000-$190,000 per year. This salary may vary depending on the individual's education, experience, and the specific company they work for. Additionally, salaries may be higher in this area due to the high demand for pharmaceutical and biotech professionals in Rahway.
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Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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