Pharmacometric Data Manager

Position Overview

The Pharmacometric group, a part of the clinical pharmacology department at Nektar Therapeutics, is expanding and is in need of a Pharmacometric Data Manager

Reporting to the Sr. Director, Pharmacometrics, the Pharmacometric Data Manager will help with preparation of data files in various formats for analysis as well as graphs and tables based on the analysis output. The position will work closely with modelers within the group and non-modelers, including other programmers, in other departments. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.

Provides strong technical programming to the Pharmacometric group within Clinical Pharmacology. Provide expertise and hands on support to pharmacometric analysis projects across multiple therapeutics areas. Successfully achieves all programming objectives through planning, project management, and technical skills. Responsible for preparation of tailored data sets required for PK/PD analysis of preclinical and clinical data. Develop SAS coding and table templates for preparing, processing and analyzing data. Generate and QC summary tables, data listings, and graphs for in-house analyses of study data or publications using SAS standard coding practices, R, or other relevant software. Create/review programming plan, specifications for datasets and TLFs. Familiar with CDISC conventions, i.e., SDTM and ADaM models and hands on experience implementing these models. Support data queries from other functional group (Medical Writing, Clinical Development, Clinical Operations, Regulatory, Marketing). Identify data quality issues. Proactively apply professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective way. Acts independently to determine methods and procedures on new assignments. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Manage CRO regarding programming issues and activities to ensure timely delivery of data files, tables, and data listings. Validate work of other programmer/analysts at CRO or in-house. Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables. Create/acquire tools to improve programming efficiency or quality. Maintaining current knowledge of programming practices and development within the industry. Contribute in development and implementation of programming standards and conventions. Duties also include serving as the primary data management liaison with Nektar Biometrics Department and vendors. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Responsible to manage the existing archiving system of the pharmacometrics' group, further develop and maintain, including preparing SOPs. Work with Nektar IT group to ensure reliable and standardized tracing mechanisms for files created by the pharmacometrics group for regulatory submissions. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).

A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and related areas is required. Equivalent experience may be accepted. A minimum 8 years relevant career experience in the pharmaceutical or biotechnology industry. Experience in NDA/BLA submission and understanding of regulatory requirements preferred. Very good knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting. Experience with other programming tools, including R and other graphing software is essential. Experience with R in data restructuring packages and data visualization packages (e.g. tidyverse, ggplot2, plotly, DT), using Rmarkdown for reporting and R-shiny for creating interactive documents and applications is a plus. Experience with producing integrated summaries for PK reports is essential. Fluent English is required. Previous experience with regulatory submission is highly desirable. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management skills and have demonstrated ability to develop data management processes and training.

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.