Overview

Serves as Lead on the project statistical level and manage internal Clinical and Statistical Programming (CSP) activities by providing broad-based programming directions. Leads the effort in process improvement by developing advanced, innovative utility tools or systems to gain productivity and efficiency. Provides leadership to the company in the area of technical expertise by acting as advisor to management and customers on advanced technical ideas and applications.

Responsibilities
• Serves as Lead on the project level to plan, organize, delegate, and manage a team from start to finish by overseeing all development, validation, and production of programs on a project.
• Manages programming activities for complex studies.
• Manages project timelines, responsibilities, and deliverables by interfacing with all levels of management to negotiate resources, project priorities, and scopes.
• Leads the effort of process improvement, including developing utility tools.
• Provides software and programming solutions across projects and/or technologies to meet business needs.
• Provides work direction and assigns tasks to lower-level programming analysts.
• Independently brings technical solutions to the internal project teams.
• Works on complex technical problems and provides solutions which are highly-innovative and ingenious.
• Provides technological application programs to accomplish global objectives.
• Provides input to project proposals in the areas of scope, budget, and timelines related to programming activities.
• Develops, revises, and maintains Standard Operating Procedures (SOPs) in conjunction with other departments.
• Monitors the quality of programs, specifications, and other programming work by ensuring the good programming practices and compliance with all the SOPs.
• Manages programming personnel in a manner that promotes problem solving, career development, and motivation.
• Completes performance appraisals and provides input for promotions, transfers, disciplinary actions, terminations, and hiring.
• Meets milestones as assigned with high-quality.
• Performs other duties as directed by DSP management.
• Performs job specific tasks in compliance with applicable Regulations, International standards, and WuXi AppTec Policies and SOPs.
• Performs other duties as assigned.

Qualifications
• Bachelor of Science or Master of Science in statistics, computer science, or related field.
• 9 years of relevant work experience with required Master of Science degree, or at 11 years of relevant work experience with required Bachelor of Science degree.
• 3 years of experience in managing programming activities for submissions.

Knowledge / Skills / Abilities:
• Expert knowledge of SAS for clinical trials is required.
• Expert knowledge of industry, such as CDISC, the ICH guidelines, 21 CFR Part 11, and FDA guidelines.
• Demonstrated expertise in the handling and processing of upstream data (e.g., multiple data forms, workflow, EDC, eDT, SDTM, and in providing outputs) to meet downstream requirements (e.g., ADaM, define.xml, and TFLs).
• Excellent organizational skills, time management, and ability to lead SAS programming activities, coordinate workload, and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Ability to work in team environment and effectively manage multiple priorities within established time constraints.
• Ability to work in satellite environment independently, but remain engaged with home office and supervisor.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.