Associate Director, Statistical Programming

Location
San Francisco, CA, United States
Posted
Jun 12, 2018
Ref
2-1-3263-525-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Provide strong technical statistical programming leadership to Statistical Programming function within Data Science and System department and be a technical resource for statistical programmer analysts. Lead technology or process initiative. Lead the design or development of global utilities and macros.
Provide expertise and hands on support to clinical projects across multiple therapeutics areas. Successfully achieves all programming objectives through leadership, planning, project management and technical skills.

Responsibilities:

Responsible for leading of design and implement clinical data analysis and reporting system.
Create/acquire tools to improve programming efficiency or quality. Lead task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry. Collaborate with Head of Statistical Programming to develop, implement and maintain SOPs and working practices for Standard directory structure and contents. Be a major Contributor to activities in statistical systems development, validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools. Contribute in development and implementation of programming standards and conventions. Lead standardization efforts (CDSIC, ADaM, and Define.xml) per EMA/FDA submission requirement. Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality. Work with IT ensuing that local IT infrastructure meets Data Science needs and global standards.
Lead in Building Statistical Programming Infrastructure. Perform vendor qualifications for system. Provides guidance on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Proactively applies professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective way. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments.

Requirements:

A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required. A Masters or PhD is preferred. Equivalent experience may be accepted.
A minimum 12 years relevant career experience in the pharmaceutical or biotechnology industry.
Prior system and Macro development experience required, familiar with the software development life cycle. Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting. Excellent knowledge of CDISC conventions, i.e., SDTM and ADaM models and hands on experience implementing these models. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
Track record of generating new ideas and solutions to data analysis. Excellent application development skills, excellent knowledge of E-Submission requirements. Excellent oral and written communication skills.

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.