JOB OBJECTIVE: The Biostatistician provides statistical expertise to the IVD clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to safety and efficacy of the product which is under development. The Biostatistician supports statistical activities in all phases of projects related to the clinical development program, and plays an active role in multi-disciplinary project and study teams.
1. Participate in Clinical Study Team meetings to design and develop statistically valid studies.
2. Responsible for making statistical model selection, experimental design, design and analysis of clinical trials and performance evaluations.
3. Analyze and interpret data from individual trials, create reports and summary documents needed to support Regulatory submissions.
4. Develop project analysis plans, including computer-generated table specifications, statistical analysis plans, and research report formats.
5. Responsible for data processing for accurate relocation, formatting, generating and transmitting required data.
6. Execute statistical plans independently for all phases of clinical studies.
7. Contribute to the development and maintenance of methods and procedures based on Regulatory Guidelines and Company requirements.
8. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Perform meta-analyses by pooling data from several studies.
2. Work with external parties to set up and manage databases needed to capture study data.
3. Assist with development of internal guidelines and SOPs.
4. Maintain up-to-date knowledge of statistical methods, concepts and techniques on design and analysis of clinical trials.
1. Bachelor’s Degree in Statistics, Biostatistics, or related field.
2. 3 to 5 years of statistical analysis experience in a clinical trials environment, including design and analysis of clinical trials.
3. Proficiency in statistical computing and report generation using statistical analysis software packages such as SAS and R.
4. Strong oral and written communication skills and attention to detail.
5. Solid understanding of business practices with fundamental understanding of project management methodology.
6. Experience in writing procedures and reviewing documents required to support regulated products.
1. Master’s Degree in Biostatistics or Statistics with at least 3 years’ experience in clinical research in a biopharmaceutical or academic setting.
2. Experience working within a quality system such as ISO 9001, ISO 13485, FDA cGMP.
3. Familiarity with nucleic acid based diagnostic tests, multiple reader multiple comparison (MRMC) studies for IVD, and population genetics.
4. Familiarity with Bayesian statistics.
5. Familiarity with database design and programming for clinical trials.
1. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, and protective gloves).
2. Ability to use computers in an interactive manner for extended periods of time.
3. Ability to travel up to 10% of the time.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.