Principal Statistical Programmer (Sanford)

Clinipace in Sanford, NC

  • Industry: Scientific Research - Electronic Engineering/Computer Science
  • Type: Full Time
  • $103,710.00 - 154,340.00
position filled

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


  • Associated topics: application developer, back end, c, c/c++, design pattern, expert, perl, senior, senior software engineer, software engineer lead

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