Clinipace Worldwide

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Principal Statistical Programmer

at Clinipace Worldwide

Posted: 9/28/2019
Job Reference #: 4215
Keywords: professional

Job Description

Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development.  Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.

Work Location:
United States | North Carolina (Morrisville)

Job Code:
4215

Job Title:         Principal Statistical Programmer

Job Location:  Morrisville, NC  office ( or US Home based, Regional)

Job Overview:        

The Principal Statistical Programmer is responsible for all aspects related to programming activities for the data preparation and analysis of clinical data.  Duties include creating all datasets, tables, listings and figures according to the specific project Statistical Analysis Plan (SAP) as well as coordinating Quality Control efforts and implementing all programming required for study/project completion. The Principal Statistical Programmer serves as a project lead and project manager for statistical programming services.

Job Duties and Responsibilities:

  • Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards, and standard operating procedures issued by Clinipace and/or clients as appropriate.

    • Conception and generation of dataset specifications

    • Design of integrated databases and development of mapping specifications for integrated datasets

    • Development and documentation of programs used to generate datasets

    • Development and documentation of programs used to generate listings, tables and graphs

    • Selection of the appropriate validation model for developed programs

    • Program validation including generation of validation documentation

    • Data preparation and documentation according to CDISC data standards

  • Preparation of electronic submission of clinical data

  • Intense and cross functional interaction with other members of the project team

  • Providing internal consultancy in various review activities like database design, data validation rules, statistical analysis plan, table shells etc.

  • Interaction with clients

  • Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied

  • Writing of User Manuals

  • Training of group members on new processes, programs etc. as appropriate

  • Initial Training on existing processes, programs etc. for new group members

  • Attending and representing the company at business conferences

  • Presenting at business conferences and professional meetings

  • Participation in industry working groups

  • Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching and education of other team members

  • Coordination of internal projects for continuous improvement of processes and systems

  • Project Management

  • External Consultancy

  • Establish and oversee highly complex programming projects

Supervisory Responsibilities:

N/A

Job Requirements:

  • Education
    • BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation

  • Experience
    • Minimum of 8 years experience in processing and analyzing clinical trial data or demonstrated aptitude for statistical programming work

    • > 6 years practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation

  • Skills/Competencies
    • Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)

    • Fluency in English

    • Expert knowledge in SAS

    • In-depth knowledge of relevant regulatory requirements

    • Good knowledge of medical terminology and conduct and analysis of clinical trials

    • Broad knowledge of different indications of clinical trials

    • Knowledge of relevant industry data standards (e.g. CDISC SDTM and ADaM etc.)

    • Ability to conceptualize and optimize project needs

  • Capabilities
    • Team player: Shows support for teamwork, cooperation, self-control, and flexibility to get the job done.

    • Comfortable working under supervision and as part of a team.

    • Practices professionalism and integrity in all actions.

    • Demonstrates honesty, trust and fairness.

    • Strong written and verbal communication skills

    • Project team leadership and project management skills

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