AbbVie Associate Project Director in Sunnyvale, California
Associate Project Director
Location: Sunnyvale, CA
# of Openings: 1
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
Provides scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug discovery or development strategies for assigned project; for the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these activities.
Key Accountabilities/Core Job Responsibilities:
Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis; and implement these standards.
Database Activities: Collaborate with Clinical Data Management, Statistical Programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project-specific data standards. Ensure accuracy and consistency of data released for statistical analysis.
Statistical skills: Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology.
Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analyses. Prepare oral and written reports to communicate results. Represent Biostatistics Department on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality.
Consultation: Interact with stakeholders so that statistical methods are adequately and consistently applied in all deliverables. Provide statistical insight in addressing questions and propose novel solutions to technical issues. Independently pursue analyses suggested by data, including the pursuit of statistical knowledge needed.
External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures, CROs or licensing activities. Build external scientific contacts which foster professional development and promote the reputation of the department. Project Team Involvement: Partner with Clinical and Regulatory to create development strategies for assigned project. Represent department on project team(s) to provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional management.
Training and Supervising: Train and mentor staff on statistical methodology and operations. Participate in department seminars, short courses and presentation of scientific articles. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed.
Demonstrated broad knowledge of, and competence in, statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, statistical simulation, and statistical programming and experience in applied statistics/statistical consulting.
Excellent SAS and R programming skills
Strong interpersonal and effective written and verbal communication skills
Pharmaceutical industry and oncology experience required.
NDA submission experience required. Global submission experience is a plus.
PhD in statistics or biostatistics with at least 6 years of experience in pharmaceutical development. Understanding of global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled