R&D Programmer II

Title: Clinical Programming Contractor SDTM & DO
Location: 100% Remote/PA
Shift Schedule: Regular 40 week working schedule (morning)
Duration: Up to 2 year assignment
Temp to Perm: Not during this time

1. Bachelors + 5 year,
   Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.

2. Proficient knowledge of clinical trials and drug development process, industry standards, database concepts used in clinical trials.

3. Strong understanding of SDTM standards and Implementation guides.

4. Demonstrates proficiency in using SAS to produce study SDTM datasets, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office).

5. Demonstrates ability to work independently and in a team environment.

1. Basic Background

2. 11 Panel Drug + Fentanyl

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 of CRFs, Data Transfer specifications, creation of SDTM specifications and datasets, and reporting the results of clinical trials, including programming rules and electronic submissions for Client`s products.

Travel Requirements: N/A

1. Primarily works at the Study, product / program level.

2. Provides comprehensive programming support, including development of programs, SDTM specifications, SDTM datasets complying with regulatory requirements, departmental SOPs and work practices, including generation of data review and operational listings and reports.

3. Man manages and delivers assignments with good quality and within timelines.

4. Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of SDTM datasets and Define packages.

5. 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.

6. Responsible for performing data handling activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics during various study milestones.

7. Responsible to support creation of case report forms (CRFs) and specifications in accordance with SDTM guideline and Client standards, including defining external (non-CRF) and support the functional review and approval process.

8. Proactively communicates issues impacting programming deliverables with Stat or DM team members.

Education Required: Bachelors Degree/Masters Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.

Experience Required:
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, database concepts used in clinical trials.
Strong understanding of SDTM standards and Implementation guides.
Demonstrated proficiency in using SAS to produce study SDTM datasets, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office).
Demonstrated ability to work independently and in a team environment.

Experience Preferred:

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 SDTM datasets and associated documents/specifications in study/project).
Have solid knowledge of Clinical data, SDTM IG and Pinnacle 21.

Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.

1. Tackles difficult problems; identifies solutions and recommends action management.

2. Influences communication toward common understanding and actionable results.

3. Good oral and written communication skills.