Serve as the statistical expert for major clinical development program(s), providing consultation and leadership in establishing the strategic direction for the program(s). Oversee all statistical activities for major clinical program(s) to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Provide strategic and expert statistical consultation to drug development, including development plans, complex study designs, cross-study analyses, statistical methodology, data analyses and interpretations, and regulatory submissions. Establish and drive program functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Work on complex problems or data requires an in-depth evaluation of various factors. Implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establish and assure adherence to budgets, schedule, work plans, and performance requirements. Serve as the statistical expert for major clinical development program(s), providing consultation and leadership in establishing the strategic direction for the program(s). Promote, evaluate, and implement as appropriate innovative clinical trial designs and efficient analysis methodologies. Ability to identify the most critical aspects of a problem/issue and use competitive intelligence to influence clinical development strategies. Oversee all statistical activities for major clinical program(s) to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Utilize appropriate internal and external resources to achieve short term and long term strategic functional goals, negotiating project timelines given constraints. Leverage standardized analysis methods and reporting standards to maximize global data integratability; identify best practices for utilization across programs. Provide statistical leadership and support for regulatory meetings, submissions and follow up, including strategic risk assessment based on statistical analyses and principles. Identify and interact with external statistical experts for issues related to study design, methodology and results. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timelines at the program level. Provide inputs for planning and management of external budgets related to statistical deliverables. Participate in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practices and its applicability in Nektar Therapeutics. Other duties as assigned
Ph.D. in Biostatistics or closely related discipline with at least 6-9 years of relevant experience; exceptional non-PhDs with demonstrated capabilities and/or significant experience may be considered. Management experience preferred. Excellent analytical and problem-solving skills with a keen understanding of statistical principles and concepts. Experience with advanced clinical study designs and analysis methods, descriptive and inferential statistics, and regulatory interactions. Specialized statistical expertise in multiple therapeutic areas or development phases. Experience representing statistics function in interactions with regulatory agencies. Advanced knowledge of the pharmaceutical industry, overall drug development process with expertise in cross-functional interactions with the statistics function. Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical studies and regulatory submissions. Strong statistical programming skills. Ability to work both independently and collaboratively within a cross-functional team. Strong oral and written communication skills, as well as, interpersonal and project/people management skills. Proven ability to directly supervise personnel, providing guidance, inspiration and motivation.
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
Internal Number: 5192-525-R
About Nektar Therapeutics
Nektar Therapeutics is a fast-growing biotech company focused on immuno-oncology with robust pipeline (https://www.nektar.com/pipeline/rd-pipeline), headquartered in San Francisco, California. We have several positions open in biostatistics at different levels. We have the growth opportunity and environment of a start-up with the financial stability of much larger company. Come join us!