Senior/Executive Director, Biostatistics

Nektar has an exciting opportunity for a Senior/Executive Director, Biostatistics on their Data Sciences and Systems Team.

Essential Duties and Qualifications

The successful candidate will have a profound understanding of adaptive trial designs and advanced analysis methodologies. Track‑record of publications related to innovative trial designs and statistical methodology. Capability of influencing senior leaders internally and externally. Proficiency in SAS statistical procedures, and ability to use other statistical software when appropriate (e.g., S‑Plus, PASS, StatXact, EaST, nQuery). Broad experience with FDA/ICH regulations and guidelines. Experience preparing and defending NDAs, BLAs, or PMAs

They will consistently work with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, developing strategy and direction for major functional areas. Requires in‑depth knowledge of the functional area, business strategies, and the company's goals. Ensures statistical integrity of study design, data analyses, and reporting of results. Develop and implement innovative clinical trial designs to increase drug development efficiency. Set vision for the statistical group and inspire staff to achieve the vision. Build external network with academic statisticians and FDA statisticians. Sets process performance goals for the department. Develops, maintains, and trains employees on department SOPs and guidelines. Prepares data and statistical components of regulatory submissions. Ensures adequate statistical support for all project teams. Supports the development and maintenance of CDPs and regulatory submission priorities and schedules. Monitors, identifies, and helps solve problems which arise during study conduct affecting statistical analysis. Supports statistical work required for out‑licensing and addresses issues raised by potential partners. Mentors statisticians in their technical work. Recruits and trains new statisticians as necessary. Supervises or performs statistical input into all major research/registration documents including clinical plans, protocols, integrated summary of safety and efficacy, integrated clinical/statistical reports, and other regulatory documents. Advises department statisticians on technical issues associated with the design, running and analysis of clinical trials. Provides statistical input into selection of IVRS vendors and IVRS specifications. Identifies the need for additional statistical, data management and clinical software and works closely with the IT department to fill the need. Keeps management informed of progress and issues impacting project goals. Reviews protocols and final study reports to ensure that statistical, clinical trial design principles, and data collection process and timing have been appropriately incorporated.

Educational Requirements

A PhD with a minimum of 12 years experience OR an MS with a minimum of 15 years experience is required.

Additional Information

Nektar currently anticipates the base salary for the Senior/Executive Director, Biostatistics to range from $300,000 to $430,000 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/Vision)
• Disability Insurance
• Holiday Pay
• Paid Time Off (PTO)
• 401(k) Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to

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.