Statistical Programmer II - Anywhere US

United States
11 Jun 2021
11 Jul 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Statistical Programmer II - Anywhere, US


Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

As a Statistical Programmer you will provide programming support to the Biostatistics and Clinical Programming functions. You will develop, create, verify/validate and maintain the programs for assigned projects in compliance with standard operating procedures. At higher levels the statistical programmer roles are expected to contribute to the improvement of overall department process and efficiencies through mentorship and identifying and contributing to departmental initiatives.

Specific tasks would include:

  • Create and maintain SAS programs for safety analysis datasets (including SDTM, ADaM, and other analysis datasets) and safety tables and listings used in the analysis and reporting of clinical trial data.
  • Perform programmatic validation of safety SDTM datasets and data listings used in the reporting of clinical trial data.
  • Create and review Pinnacle 21 reports and investigate as necessary.
  • Maintain study documentation according to Standard Operating Procedures.
  • Document and communicate data issue findings to data management through recording them in the data issue log.
  • Awareness of time available to complete tasks and work with study lead and manager to manage effort.
  • Assist with ad-hoc programming as requested.
  • Regularly participate in ongoing department training and development opportunities.
  • Create and maintain SAS programs for efficacy analysis datasets (including SDTM, ADaM, and other analysis datasets) and efficacy tables and figures used in the analysis and reporting of clinical trial data.
  • Perform programmatic validation of analysis datasets and safety tables and figures used in the reporting of clinical trial data.
  • Create, review, and maintain programming specifications for SDTM, safety ADaM datasets, and other safety analysis datasets.
  • Create with guidance programming specifications of efficacy ADaM datasets and other efficacy analysis datasets.
  • Assist with CRF annotation.
  • Assist with programming specific study start-up activities.
  • Assist with Define.xml and Data Reviewer guide creations.
  • Assist with Listing/Table/Figure shell annotation.
  • Support other departments by assisting in programmatic edit checks of raw data.
  • Provide effective communication within the programming team and across departments where necessary to create quality output in a timely manner.
  • Maintain awareness of study budgets and scope of work and support study lead in staying on track.
  • Lead study team, with guidance, to the successful completion of simple projects within the parameters of timelines and budgets.
  • Contribute to department initiatives where appropriate.

  • Bachelor's degree or equivalent in mathematics, statistics, or related field of study and a minimum of 2 years related experience or equivalent combination of education and experience.
  • Intermediate proficiency in BASE SAS or other statistical software.
  • Possesses understanding of data management and programming issues associated with clinical trials.
  • Possesses a basic understanding of CDISC standards and requirements.
  • Possesses a working knowledge of ICH/GCP standards, 21 CFR Part 11, FDA and other applicable country regulations.

This job excludes Colorado applicants.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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