PRINCIPAL STATISTICAL PROGRAMMER

SPAULDING CLINICAL RESEARCH LLC•West Bend, WI

1d•$50 - $50•Onsite

About The Position

Principal Statistical Programmer role will work as a part of a multi-dimensional project team focused on delivering quality and timely deliverables for a variety of pharmaceutical and biotechnology clients. The Principal Statistical Programmer will build the appropriate programs in order to create SAS datasets from the clinical database and other data sources as outlined in the clinical study's protocol, Clinical Data Management Plan, and/or Statistical Analysis Plan. The Principal Statistical Programmer will develop SAS macros, templates and utilities for data cleaning, reporting and analysis. The Principal Statistical Programmer has expert knowledge of Clinical Data Interchange Standards Consortium (CDISC) Guidelines and Requirements.

Requirements

Proficiency in SAS.
Knowledge of the programming and reporting process.
Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
Demonstrate ability to learn new systems and function in an evolving technical environment
Strong leadership ability.
Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently.
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
Attention to detail.
Excellent analytical skills.
Excellent presentation skills.
Tenacity to work in an innovative environment.
Ability to negotiate and influence in order to achieve results.
Business/Operational skills that include customer focus, commitment to quality management and problem solving.
Good business awareness/business development skills (including financial awareness).
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
Work effectively in a quality-focused environment.
Demonstrate commitment to refine quality processes.
Effective time management in order to meet daily metrics or team objectives.
Show commitment to and perform consistently high quality work.
Competent in written and oral English.
Excellent communication skills.
Experience in Biostatistical Analysis & SAS Programming for clinical trials in the medical device, pharmaceutical or biotechnology industry.
Minimum of five years of programming experience in a clinical trials environment
Project leadership experience required.
Degree in Information Management, Computer Science, Mathematics, Statistics, or related discipline.

Nice To Haves

Expert knowledge of Clinical Data Interchange Standards Consortium (CDISC) Guidelines and Requirements.

Responsibilities

Deliver best value and high-quality service.
Ability to fill Statistical Programming Coordinator role on projects.
Input into and negotiate statistical programming timelines.
Ensure that timelines are adhered to.
Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
Monitor project resourcing, project budgets, and identify changes in scope.
Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
Be trained in sponsor SOP’s and disseminate knowledge to project team members as appropriate.
Proactively participate in and/or lead process/quality improvement initiatives.
Work closely with Quality Management to ensure compliance with SOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage and processes within Biometrics.
Maintain and expand local and international regulatory knowledge within the clinical industry.
Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for Biometrics and sponsors.
Provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.
Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
Maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders.
Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy).
Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and required documentation.
Review CRF’s to ensure consistency with protocol and adequacy to collect the data to meet the objectives defined in the statistical section of the protocol and SAP.
Review CRF annotations and database data specifications.
Interface with Data Management and clinical teams to identify and program edit checks per the Data Validation Plan/Data Management Plan and study management reports using SAS.
Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
Provide input into forecasts and monitor the completion of forecasted units.
Create standard macros and applications to improve the efficiency of the department.
Assessment of technology and processes, to facilitate best practices, increase quality, efficiency, and productivity.
Consult with sponsors on technical/regulatory issues.
Represent the company at sponsor marketing and technical meetings.
Represent Statistical Programming on cross-functional technical initiatives.
Contribute to the development and delivery of internal and external technical training seminars and courses.
Mentor and train other members of the department.
Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
Develop mapping specifications for data exports in accordance with applicable standards.