Director, Statistical Programming
Company Name:-
Nektar Therapeutics
Job Location:-
San Francisco, CA 94158 (Mission Bay area)
Job Summary:-
Position Overview
Nektar has an exciting opportunity for a Director, Statistical Programming to join their team.
Provide strong technical statistical programming leadership to Statistical Programming function within DSS 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.
Contribute in 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.
Will typically have individual contributors and management staff reporting into this level.
Essential Duties and Responsibilities:
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercise judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ensure budgets, schedules and performance requirements are met.
Work with IT ensuing 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.
Lead standardization efforts (CDSIC, ADaM, and Define.
xml) per EMA/FDA submission requirements.
Provide timeline and resource forecasts for statistical programming deliverables.
Mentor statistical programmers on team performance and relevant therapeutic areas.
Hiring of additional staff.
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 program
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