Principal Statistical Programmer Analyst

Location
San Francisco, CA, United States
Posted
Oct 04, 2019
Ref
3646-525-2019
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Provide strong technical statistical programming to Statistical Programming function within Biometrics.

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.

Responsibilities:

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).

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. 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.

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.