Sr. Statistician, Research in Lake County, IL
- Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies
- Develop standardized reusable JReview Objects and Views. Work with Medical Safety Evaluation (MSE) and PST Statisticians to formulate, conduct, and interpret appropriate queries of safety data using JReview and other analytic tools. Develop, as needed, ad-hoc JReview objects and views for evaluating potential safety signals. Champion and promote the use of safety review tools (e.g., JReview and SDRT) among PST physicians and MSE.
- Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety date & for benefit-risk analyses
- Works collaboratively with multi-function teams to complete project deliverables per agreed timelines. Keeps management Informed on important scientific/statistical issues that may arise, in a timely manner.
- Provides responses to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data. Responsible for developing and maintaining good client relationships
- Communicates a basic understanding of scientific principles for assigned projects and acts in accordance with those principles. Clearly communicate fundamental statistical concepts to other statisticians, scientists, and other personnel.
- Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings
- Presents own statistical research or review of the statistical literature at meetings and seminars.
- Participates in departmental activities including recruiting , training/mentoring, research efforts and cross-functional collaborations, as necessary
- MS or PhD in Statistics, Biostatistics or a highly related field. 0+ years (PhD) or at least 4-6 years (MS) of relevant experience required
- High degree of technical competence and sound communication ability, both oral and written
- Competent in experimental design, descriptive and inferential statistics, biometrics/biopharmaceutical applications and computer programming.
- Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Learns fast, grasps the 'essence' and can change the course quickly where indicated
Visa Candidate Considered: Yes
Base Salary - $100,000 to $125,000
Full-time Benefits - Full
Relocation Assistance Available - Yes
5+ to 7 years experience
Seniority Level - Mid-Senior
Minimum Education - Master's Degree
Willingness to Travel - Occasionally
Sr. Associate, Regulatory Affairs Manager International in San Rafael, Ca
We are seeking a highly motivated, energetic professional capable of working effectively in a fast-paced environment to join our Regulatory Affairs International team. The Regulatory Affairs International Manager is responsible for supporting global regulatory activities for new product registration and life-cycle maintenance in Latin America, Asia Pacific, Eastern Europe/Asia Minor and Middle East/Africa.
- Understand regional laws, regulations, guidance, and global regulatory requirements while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.
- In conjunction with regional leads and experts, manage project timeline, planning and preparation and submission of marketing applications, orphan drug applications and variations to support LATAM, APAC and EEAM/MEA regions. Must ensure all submissions are prepared in accordance with regional regulations.
- Participate on interdisciplinary regulatory teams in establishing global regulatory strategy
- Provide regulatory support to team members located in global offices.
- Manage the writing or updating of various sections of the MAs including the administrative, labeling, nonclinical, and clinical portions of MAs.
- Act as a main point of contact for specific projects and serve as an international regulatory representative on project sub-teams. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry.
- Participate in international health authority meetings, as required.
- Communicate with regulatory consultants regarding product development plans.
- Perform regulatory intelligence searches for registration and other regulatory requirements in applicable global regions.
- Flexible work schedule to maximize global interactions, as required.
- Up to 10% travel for regional business, health authority meetings, etc. may be expected.
- Minimum of 4-5 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experience preferred.
- Proven ability to manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
- Ability to successfully manage multiple projects to deadlines.
- Thorough understanding of relevant drug development and post-marketing regulations and guidelines and have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
- Skilled at gathering supportive information and developing product approval strategies.
- Proven track record of achieving regulatory goals in ambiguous and sometimes challenging situations.
- Rare disease experience is preferred
- International experience is preferred
- Bilingual/multilingual language skills are a plus
- Bachelor's degree in a science/life sciences.
Base Salary - $90,000 to $120,000
Relocation Assistance Available
5+ to 7 years experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally