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Nektar Therapeutics

    Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and oth... Read More

Address      455 Mission Bay Boulevard South San Francisco, CA 94158
Website      www.nektar.com/
Holding      No Holding Details

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Principal Statistical Programmer Analyst

 Position Summary
Provide strong technical statistical programming leadership to Statistical Programming function within BDM and be a technical resource for statistical programmer analysts. Serve as mentor to statistical programmers. 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.
Provide strong technical programming support to Biometrics and Data management and be a technical resource for statistical programmer analysts
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 Building Statistical Programming Infrastructure.
Contribute in development and implementation of programming standards and conventions.
Perform vendor qualifications in regards to statistical programming function and oversees and validate vendor's programming activities such as CDISC implementation, analysis files specifications, and analysis, and programming conventions.
Work closely with Data Management at Nektar to develop applications.

Proactively applies professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective way.
Provides guidance on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Acts independently to determine methods and procedures on new assignments.
Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4.
Initiate programming environment. Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices.
Create/acquire tools to improve programming efficiency or quality.
Validate work of other programmer/analysts at CRO or in-house.
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.
Perform vendor qualifications
Manage CRO regarding programming issues and activities to ensure timely delivery of tables and data listings.
Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables.
Participate in the lead task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry.
Collaborate with Head of Biometrics and Data Management to develop, implement and maintain SOPs and working practices for: Standard directory structure and contents.
Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality.
Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
Support data queries from other functional group (Medical Writing, Clinical Development, Clinical Operations, Regulatory, Marketing).

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.
Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment in particular clinical trial data setting.
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.
Thorough understanding of relational database components and theory.
Excellent oral and written communication skills.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

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Contact Name:

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Job Duration:

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