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Director, Statistical Programming

Employer
Nektar Therapeutics
Location
San Francisco, CA
Start date
Sep 8, 2021

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Discipline
Information Technology, Bioinformatics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Provide strong technical statistical programming leadership to the statistical programming function within BDM and provide technical guidance to 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. Contribute to building statistical programming infrastructure. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Essential Duties and Responsibilities:

Ensures budgets, schedules and performance requirements are met. Work with IT ensuring that local IT infrastructure meets Biometrics needs and global standards. Adhere to principles of GCP. Develop, apply, and promote consistent programming standards through standard processes and SOPs. Identify areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify.

  • Administratively and functionally manage statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development. Mentor statistical programmers on team performance and relevant therapeutic areas. Hiring of additional staff.  
  • Lead standardization efforts (CDSIC, ADaM, and Define.xml) per EMA/FDA submission requirements. Provide timeline and resource forecasts for statistical programming deliverables.
  • 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.
  • Create/acquire tools to improve programming efficiency or quality. Validate work of other programmer/analysts at CRO or in-house.
  • 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 new initiative roll out, while maintaining current knowledge of programming practices and development within the industry. 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. Ensure SOPs have been developed properly. Ensure statistical programming tasks have been conducted in a compliant and timely manner with high quality across all projects.
  • Ensure computer systems and networks are set up appropriately. Lead standardization efforts (CDSIC, ADaM, and Define.xml) per EMA/FDA submission requirement. Provide timeline and resource forecasts for statistical programming deliverables.

Minimum Qualification Requirements:

A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, or related areas is required. A Masters or PhD is preferred. Equivalent experience may be accepted. A minimum 12-15 years relevant career experience in the pharmaceutical or biotechnology industry. A minimum 5-7 years experience managing statistical programming groups and activities. Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environments, in particular clinical trial data setting. Experience with Clinical Study Reports and NDA submissions. Expert level statistical programming in a pharmaceutical or CRO environment.  Experience working in a FDA regulated environment required. Excellent knowledge GCP regulations and guidelines. Strong well-rounded technical skill, SAS, CDISC, Submission CRTs. Advanced technical knowledge of FDA, EMA, and ICH guidance; CDISC and ADaM and electronic submissions.  Advanced knowledge of integrated summary of data. Strong understanding of clinical trial data and extremely hands on in data analysis and reporting. Thorough understanding of relational database components and theory. Excellent oral and written communication skills.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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