Contract Programmer [Contract]

Overview

The Contract Programmer  is responsible for managing, planning and tracking the Statistical Programming activities and managing the Statistical Programming staff and resource to ensure corporate activities and goals are met. The Contract Programmer will build and enforce the appropriate standards in the department.

Essential Functions and Responsibilities

• Oversees the work of direct reports to ensure on-time, on-target and within-budget results
• Maintains good communication with data management and clinical operations.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data.
• Oversees and manages the work flow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
• Acts independently to determine methods and procedures on new assignments.
• Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Manages creating CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
• Manages the activities of Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Reviews Data Management Plan, Data validation plan and edit check specifications.
• Interacts with Statisticians and other clinical team, performs ad hoc analysis and generates outputs according to the requirements.
• Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
• Recognizes inconsistencies and initiates resolution of data problems.
• Manages the development of SAS coding and table templates for preparing, processing and analyzing clinical data.
• Creates/acquires tools to improve programming efficiency or quality.
• Establishes monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• MS or higher degree in Statistics, Math or Scientific Discipline.
• 5-8 years Pharmaceutical/Biotech programming experience.
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Prior management/supervisory experience.
• Ability to use professional concepts to achieve objectives in creative and effective ways.
• Experience in the analysis of complex Oncology clinical trial data.
• Experience in managing in multiple projects.
• Ability to use professional concepts to achieve objectives in creative and effective ways.
• Solid knowledge of SAS Programming language.

Preferred Education, Skills, and Knowledge 

• Experience working with Oncology trials and NDA or BLA submission experience is highly desirable.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

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The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.  

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