San Francisco, California, United States
Job type: fulltime
Job industry: Science & Technology
Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials.
Contributes to clinical study, designs and performs statistical analyses and develops tracking systems for clinical data. Directs the evaluation and design of clinical data statistics. Must have expertise in state-of-the-art manipulation and statistical methodology. Oversees all ancillary activities supporting high-quality output from the biostatistical department. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas. Interacts internally and externally with executive level management to negotiate complex matters to influence policymaking. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Directs and coordinates the activities of biostatistics projects with responsibility for results with relationship to cost, methods and employees. Ensures budgets, schedules and performance requirements are met. Directs the preparation of required documentation according to company and/or regulatory standards. Communicates with various internal and external audiences such as, scientists, engineers, clinicians, quality staff and partners as required. Ensures adequate resources and budgets to support the Company's clinical biostatistics service group, while fully understanding their strategic business implications. Ensures adequate procedures and processes are in place for the biostatistics operation and that results are documented according to established company policies and all relevant regulatory mandates. Provides strategic input on, protocol design and clinical trial data analysis, development of statistical analysis plans and statistical methodology sections of planned protocols, and oversight of programming support and of any outsourced biometric responsibilities. Is a key statistical interface with Regulators, crafting responses to relevant Regulatory questions, and ensuring the generation of high-quality clinical trial data to aid in programmatic decision-making. Plays a major statistical leadership role in the support of Regulatory filings and submissions. Contributes substantively to the development of charters for DSMBs and Endpoint Adjudication Committees and may serve as a sponsor liaison with these committees. Directs the development, review and approval of relevant SOPs, and CRF design. Prepares and provides written reports, presentations and publications as required. Identifies, develops and delivers internal biostatistics training courses as required. Directs the utilization of resources and identifies when and where additional resources may be needed to provide effective statistical support to customers. Responsible for providing regular performance feedback, development and coaching to direct reports.
A minimum of a Bachelors degree in a statistics discipline is required. An advanced degree in a statistics discipline is preferred. Equivalent experience may be accepted. A minimum of 13 years experience in statistics related to the pharmaceutical industry is required. A minimum of 10 years previous management experience is preferred. Previous experience working in a quality regulated environment with a thorough understanding of cGMPs is highly preferred. Must have a thorough understanding of SAS. Must be able to demonstrate expert knowledge of statistical principles and concepts. Must be able to demonstrate strong project management skills. Previous experience designing and delivering presentations/trainings is required. Strong oral and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Experience working in a team-focused environment is preferred. Excellent computer skills are required. Must be detail oriented. Must have an ability to create and manage internal and external technical and business relationships, representing the company in a highly professional manner.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.