Clinical Programming – Contractor – Analysis and Reporting (ADaM)
Iconma
West Chester, PA
JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Outcomes, Clinical Research, Clinical Trial, Communication Skills, Computer Programming, Cross-Functional, Data Analysis, Data Sets, Debugging Skills, Drug Development, Genetics, Government Regulations, Health Plan, ICH Regulations, Industry Standards, Information Technology & Information Systems, Microsoft Office, Pinnacle, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Product Programs, Project/Program Management, Publications, Quality Control, Regulatory Requirements, Safety/Work Safety, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistical Modeling, Statistics, Team Player, Time Management, Writing Skills, XML (EXtensible Markup Language)
LOCATION
West Chester, PA
POSTED
Today
Responsibilities:
- The Clinical Programming (Contractor) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
- The clinical programming contractor independently manages completed projects that involve global tasks, or cross functional teams The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for our marketed drugs.
- Primarily works at the Study, product / program level
- Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLFs) complying with regulatory requirements, departmental SOPs and work practices.
- Manages and Delivers assignments with good quality and within timelines
- Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
- Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
- Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement
- Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Requirements:
- Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
- Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data
- Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
- Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.
- Strong understanding of SDTM, ADaM standards and Implementation guides.
- Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
- Demonstrated ability to work independently and in a team environment.
- Specialized or Technical Knowledge Licenses, Certifications needed:
- Functional Knowledge: Expert level of programming skills and problem resolution in SAS.
- Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspections).
- Have solid knowledge of statistical models used for efficacy data analysis.
- Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.
- Tackles difficult problems; identifies solutions and recommends action management
- Influences communication toward common understanding and actionable results;
- Good oral and written communication skills.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
About the Company
I
Iconma
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
COMPANY SIZE
2,000 to 2,499 employeesINDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/