Sage Therapeutics

Sr. Clinical Statistical Programmer

US-MA-Cambridge
2 weeks ago(11/29/2017 9:14 AM)
ID
2017-1395
# of Openings
1
Category
Clinical

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. They will provide technical and programming expertise for assigned studies, and works independently to support various programming activities related to the analysis and reporting of clinical study data. 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:

  • Develops computer programs using SAS to
    • Perform the necessary manipulations to import external data into SAS or export SAS output to other computer files.
    • Create very derived data sets (e.g., adverse events with multiple merging and cleaning procedures) and performs other advanced data manipulation.
  • Assists 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.
  • Assists 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.
  • May be required to assist in other programming tasks using software other than SAS (e.g. SQL) to support specialized data analysis requirements.
  • Ensures that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines.
  • Prepares documents to describe SAS programs and databases for large projects.
  • Performs group and departmental Quality Control (QC) procedures.
  • May be required to assist with database development responsibilities.

Experience, Education and Specialized Knowledge and Skills

 

  • MS in biostatistics, mathematics, statistics, computer science or equivalent degree, with at least 1 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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