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VP of Statistical Science

Company: Pharmaceuticals, Emeryville, CA
Location: Emeryville
Posted on: May 17, 2018

Job Description:

The Vice President, Statistical Science, will build and oversee data management, biostatistics, and statistical programming for the clinical research, medical affairs, and research teams. This position will be the Company representative both internally and externally on all matters related to biometrics. This position will report to the Senior Vice President, Clinical Research and is based in Emeryville, CA. Specific Responsibilities: Provides statistical and data management leadership for IND / NDA submissions, health authority queries, and advisory committees; Responds to statistical questions raised by regulatory agencies and assists with statistical aspects of regulatory agency negotiations; Authors data management plans and defines database requirements to ensure high-quality and analyzable data sets and provides statistical programming requirements; Owns all statistical deliverables for CRFs, SAPs, CSRs, ISE / ISS documents, publications, and presentations, including but not limited to: Provides input to study design Responsible for statistical section of clinical trial protocols Ensures that appropriate analysis procedures are used and study reports accurately describe statistical methods and results of analyses Develops, implements, and manages SAPs and programming specifications Generates and/or verifies sample size calculations and randomization schemes Provides input to study database requirements and works closely with clinical data managers to ensure data quality standards are met Reviews case report forms to ensure that protocol objectives are met and project data standards are maintained Owns all clinical trial database deliverables, including but not limited to: Reviews and finalizes clinical study database validation plans Prepares electronic data transfer protocols and ensures proper data transfers (import and exports) with 3rd party vendors and consultants Coordinates with Medical Monitor, Pharacovigilance representative, and Clinical Project Manager in review and approval of coding for adverse events, and reconciliation of safety database with clinical trial adverse event database Leads data cleaning and lock activities Collaborates with the QA department on database audits Partners with internal and external teams to compile and maintain IT master SAS data dictionary Creates an environment that engenders trust and encourages open exchange of ideas at all levels, across functions, departments, projects, and geographies; In collaboration with clinical team, interprets trial data and recommends most informative and insightful data display; Establishes and maintains effective working relationships with subordinates, peers, project teams, and senior management; Identifies goals and priorities that support the short- and long-range business strategies. Ensures planning is done well the first time to minimize inefficiencies in process; anticipates and adjusts for problems and roadblocks; Identifies areas that require systematic approaches in order to build scalable processes over time; Collaborates with external partners, and owns the relationship. Oversees CRO statistical and programming activities. Takes timely corrective action, as needed Communicates and shares information effectively with all level of the organization and in a variety of presentation settings. Can get messages across that have the desired effect both in formal presentation and information meetings; Leads change initiatives and makes suggestions for increasing the effectiveness of the department, as well as, the organization; Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations. Qualifications: PhD in statistics or related discipline; Minimum of 10 years’ experience in clinical drug development, including at least 5 years in a management function; Recent NDA / BLA submission experience is a must, with eCTD formatting preferred; CNS and/or psychiatry drug development experience preferred; Proven track record of effectively managing CROs and external partners to ensure high quality, on-time, and on-budget statistical outputs Can effectively anticipate and manage risks; Able to use rigorous logic and sound methods to solve difficult problems; Must be a thought leader, as evidenced by a publication and recent NDA/BLA track record; Working knowledge of a wide variety of principles, theories, and concepts in statistics and experimental design. Must be able to apply them to the development and analysis of clinical trials. Thorough understanding of ICH GCP guidelines. Proficiency in statistical analyses using SAS. Working knowledge of data management standards; Established communicator / educator of statistical principles to both technical and non-technical colleagues. With respect to health authority interactions, has successfully lead statistical discussions; Prior advisory committee experience preferred; Excellent written and verbal communication skills a must; Experienced collaborator with other drug development colleagues, with an emphasis on quantitative decision-making as it relates to study design options and clinical / statistical trade-offs; Consistent builder of effective biostatistics and programming teams, both internally and externally (consultants / contractors); Enjoys and prefers a small growing company environment, where s/he must equally comfortable with leading, stewarding, doing, and building; Ability to see long-range vision and develop supporting strategies in order to build and scale the function; Flexible, adaptable, respectful, and able to effectively deal with ambiguity; Successful experience in fast-paced entrepreneurial environment Fit with Company culture and values

Keywords: Pharmaceuticals, Emeryville, CA, San Francisco, VP of Statistical Science, Executive, Emeryville, California

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