Posted: Friday, January 5, 2018 8:29 PM
About The Opportunity: Our client is a global, research-based biopharmaceutical company. Their mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Our client employs over 20,000 people globally and markets medicines in more than 170 countries. The area of oncology is a key therapeutic area with a portfolio consisting of three marketed products. In addition, a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. Our client is expanding its oncology hub on the West Coast. They are focused on the discovery and development of novel oncology therapies. Over 1,000 scientists, clinicians, and product developers with strong entrepreneurial roots work across various sites. 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. The Senior Manager of Clinical Statistics will provide statistical support for development strategy for clinical or scientific research programs. This Is Your Day To Day: - Oversees or partners in development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis. - Demonstrates extensive understanding of statistical concepts and methodologies. - Proposes new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results. - Provides sufficient detail to allow programming implementation. - Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately. - Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. - Prepares oral and written reports to effectively communicate results of clinical/scientific research to management, project teams, regulatory agencies, or individual investigators. - Represents Data and Statistical Sciences or Biometrics on project issues at management review meetings and project team meetings. - Provides in-depth scientific/statistical review for scientific reports and publications. - Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality. -Partners with multiple stakeholders to develop scientifically appropriate development strategies for assigned drug discovery or development project. Effectively plans and coordinates statistical resources to best meet assigned project priorities. - Works with Director and appropriate administrative staff to manage alternative resources (ie, consultants, CROs, interns, temporary staff) to satisfy needs for assigned project. - Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications. - Provides scientific/statistical insight in addressing questions from clients, and proposes novel solutions to technical issues. - Independently pursues analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue. - In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements. - Acts as the liaison for statistical issues on collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. - Builds external scientific contacts which foster professional development and promote the reputation of the department. - Demonstrates good understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development. - Critically reviews regulatory submission documents for assigned drug discovery or drug development project. - Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists. - Partners with Clinical and Regulatory to develop scientifically appropriate development strategies for assigned project. - Represents Biometrics on project team(s) to provide functional area input to compound/drug development and ensures alignment with functional management. - Leads the communication between assigned project team(s) Biometrics functional area to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional management. - In conjunction with Associate Director and/or Director, coordinates statistical support for assigned drug discovery or development project. - Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations. - Mentors and/or manages personnel when appropriate by delegating assignments, reviewing activities and defining/ensuring review of deliverables so that projects are completed on time with high quality. - Fosters the scientific development of staff. - Participates in department seminars, short courses, and the publication presentation of scientific articles. - Works with Associate Director and/or Director to arrange training opportunities for staff to facilitate their timely career development. - Works with Director and/or appropriate administrative management to recruit qualified statisticians to the organization. - Ensures that staff (if appropriate) and self are compliant with training requirements. - Demonstrates a high degree of responsibility in maintaining Biometrics standards, GxP compliance, and best operating practices for staff (if appropriate) and self. - Coordinates statistical resources within and across sites to effectively utilize resources. - Reviews key decisions impacting project timelines with department management. - Has a strategic focus on assigned drug discovery or development project and optimizes execution. - Works with Director to build relationships between Biometrics and outside investigators and medical/scientific experts. - Ensures that all applicable regulatory requirements for work processes are met. - Participates in discussions with regulatory agencies as needed. - Consistently demonstrates excellent record of achievement with respect to Biometrics and business objectives. This Is What You Bring To The Table: - High degree of technical competence and effective oral and written communication skills. - Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge concerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications. - Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred. - Works collaboratively with function management and multiple stakeholders to develop strategies for addressing issues/requirements that arise in clinical, nonclinical or pharmacology programs, as appropriate. - Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. - Learns fast, grasps the 'essence' and can change the course quickly where indicated. - 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 Education Background & Experience: Ph.D. in Statistics or Biostatistics + a minimum of 4 years of pharmaceutical or CRO experience. Personify is an EOE About Us: Personify's mission is simple, to empower our clients to create an optimized hiring process while delivering a world-class experience. As a Customer Service Organization, Personify offers customizable solutions that bridge the gap between traditional executive search firms and typical Recruitment Process Outsourcing providers. We offer an innovative, systematic process designed to revolutionize our clients' overall approach to talent. Our system integrates Business Intelligence and Analytics with Recruitment to create a complete Talent Management Solution. We are business consultants to our clients and trusted career advisors to our candidates.
• Location: San Francisco
• Post ID: 93137332 sf