Principal Statistical Programmer

Parexel Jacksonville , FL 32277

Posted 3 months ago

Be part of our empowered Parexel Statistical Programming team today!

Principal Statistical Programmer (with SDTM experience) - to contribute to meaningful advances that benefit patients in need.

Location - Home based US

As a Principal Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. Parexel will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environment

KEY RESPONSIBILITIES include (not an exhaustive list of duties):

  • 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

  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance

  • Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors

  • Provide leadership, project specific training, stakeholder management, external sponsor support,resource management, and project management for the required programming tasks supporting clinical trial activities

Qualifications

Skills

  • Proficiency in SAS

  • Knowledge of the programming and reporting process

  • Knowledge of WSOPs/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

  • Strong leadership skills

  • Ability to successfully work together with a ("virtual") team (including international teams as required) as well as independently

  • Excellent analytical skills

  • Effective time management in order to meet daily metrics or team objectives

Education

  • Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills

  • Excellent communication skills both verbal and written

Required skills and experience:

  • 7+ years proficiency in SAS programming

  • 2+ years of ADaM, CDISC or SDTM

  • Lead experience in a Pharma setting

  • Attention to detail, ability to be self-driven and solid organization skills

  • Excellent communication skills (verbal and written)

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Statistical Programmer

Iqvia Holdings Inc

Posted 3 months ago

VIEW JOBS 9/15/2021 12:00:00 AM 2021-12-14T00:00 Job description Location: Homebased anywhere in the US or Canada Purpose: Experienced R programmers needed to provide technical expertise to develop process methodology for department to meet internal and external clients' needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Job Details: * Position: - Principal Statistical Programmer * Home Based * Min 4+ years of CRO/Pharma Industry * Therapeutic Areas: Oncology // Immunology // IDV // EDCP Key Skills: * Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros. * Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. * Must have excellent knowledge of CDISC standards (SDTM and ADaM) * Thorough understanding of relational database components and theory. * Excellent application development skills. * Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. * Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes. * Minimum of 4+ years of experience in Statistical Programming in pharmaceutical or medical devices industry * Good verbal and written communication skills. * Ability to work on multiple projects, plan, organize and prioritize activities. Required Knowledge, Skills and Abilities: * Experience as technical team lead directly engaging clients and coordinating tasks within a programming team * In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Knowledge of statistics, programming and/or clinical drug development process * Advanced knowledge of R programming * Base SAS, SAS/STAT, SAS Graph and SAS Macro Language * Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards. * Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL. * Good organizational, interpersonal, leadership and communication skills * Ability to independently manage multiple tasks and projects * Ability to delegate work to other members of the SP team * Excellent accuracy and attention to detail * Ability to delegate work to other members of the SP team [SPM] * Exhibits routine and occasionally complex problem-solving skills * Ability to lead teams and projects and capable of managing at a group level * Recognizes when negotiating skills are needed and seeks assistance. * Ability to establish and maintain effective working relationships with co-workers, managers and clients. Responsibilities: * Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files  for internal and external clients and (iii) the programming  quality control checks for the source data and report the data issues periodically.. * Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. * Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies. * Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. * Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. * Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables. * Use and promote the use of established standards, SOP and best practices. * Provide training and mentoring to SP team members and Statistical Programming department staff. MINIMUM REQUIRED EDUCATION AND EXPERIENCE: * Bachelor's degree from reputable university preferably in science/ mathematics related fields At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation. Iqvia Holdings Inc Jacksonville FL

Principal Statistical Programmer

Parexel