Sage Therapeutics

  • Senior Clinical Statistical Programmer

    Job Locations US-MA-Cambridge
    Posted Date 1 week ago(7/9/2018 12:02 AM)
    ID
    2018-1999
    # of Openings
    1
    Category
    Corporate Communications
  • Overview

    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for ensuring the robust application of clinical data and statistical programming methodologies to support the development and execution of clinical development strategies to deliver medically-differentiated therapies that provide meaningful improvement to patients. Statistical Programming personnel work closely with the biostatistics, data management. Medical writing, and clinical operations development functions to ensure that Sage’s development programs and their component clinical studies have timely and high quality deliverables. Statistical Programming personnel participate in the development and execution of clinical study protocols, case report forms, and data management plans, and support data monitoring and cleaning ro enable effective and efficient clinical trial execution.

    Roles and Responsibilities

    The Senior Statistical Programmer is responsible for all statistical programming deliverables in support of the design, conduct, analysis and reporting phase of one or more clinical trials. He/she works independently to support various programming activities related to the analysis and reporting of clinical study data. The Senior Statistical Programmer will also serve as statistical programming coordinator on one or more programs, working closely with the statistical programming program lead, study biostatistician and biostatistics program lead, study data manager, study medical writer, and other functional area study leads as required. General areas of responsibility also include import/export programming, specification development, analysis datasets (e.g., SDTM/CDISC, ADaM) creation, as well as mapping specifications to support relevant data standards. The successful candidate will:

    • Develop computer programs using SAS and performs the necessary manipulations to import external data into SAS or export SAS output to other computer files
    • Develop computer programs, using primarily SAS, to create and derived data sets and perform other advanced data manipulation
    • Assist with the development of advanced computer programs, using SAS and other software if necessary, to perform system tasks and macros/utilities to increase the quality and efficiency with which results are produced
    • Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines
    • Assist in other programming tasks using software other than SAS (e.g. SQL) to support specialized data analysis requirements
    • Prepare documents to describe SAS programs and databases for large projects
    • Perform Quality Control (QC) procedures
    • Assist with the development of computer programs, using primarily SAS, which generate complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
    • Assist with database development responsibilities
    • Enjoy working collaboratively as part of a team
    • Be capable of handling multiple priorities
    • Adapt to changing priorities, take initiative and follow through on own
    • Be attentive to details and ability to independently resolve a variety of issues without close supervision
    • Be and independent creative thinke
    • Have excellent customer relation skills
    • Be able to manage multiple projects/tasks, and appropriately prioritize these tasks
    • Be able to oversee programming work performed by Contract Research Organizations

    Experience, Education and Specialized Knowledge and Skills

    • MS in biostatistics, mathematics, statistics, computer science or equivalent degree, with at least 3+ year experience; or BS with 5+ years of relevant pharmaceutical industry work experience.
    • Experience with the CDISC, SDTM and AdaM models, and transforming raw data into these standards
    • Proficiency in SQL and PL/SQL programming
    • Proficient in SAS programming, including BASE, FSP and SAS macro programming
    • Understanding of SAS database structures and experience with at least one Clinical Database Management System (e.g. Oracle Clinical, Clintrial, eDM, etc.)
    • Excellent communication skills (verbal, written and interpersonal)
    • Regulatory submission programming is a plus
    • Ability to work well within multi-disciplinary teams and has proven abilities to coordinate and drive projects in a matrix organization
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Excitement about the vision and mission of Sage

     

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