Associate Director/Director - Programming Head – AdaM Programmer

Replimune Group

Woburn, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 03/31/2021
  • Website: replimune.com
  • Company Address: 18 Commerce Way, Woburn, MA, 01801

About Replimune Group

Replimune is working to advance the science of oncolytic immunotherapy to improve on existing therapies and help treat more patients with a variety of tumor types. Oncolytic immunotherapy uses viruses that have been modified to selectively replicate in and kill tumors.

Job Description

The Analysis Programmer (SAS, ADaM) leads the development and maintenance of statistical programming infrastructure, programming standards, conventions, standard reporting systems and macro utility programs to ensure timely, quality, and cost-effective delivery of tables, listings, and graphs in support of Biometrics across all clinical and pre-clinical projects.

Key Responsibilities
  • Direct the development and administration of global statistical programming group policies and procedures (SOPs) and work instruction manuals to ensure compliance with regulatory standards. 
  • Establish and manage a global programming quality review and control program with appropriate Quality Control and monitoring procedures to insure proper implementation.
  • Select, hire, train, and supervise Programming staff, contract and temporary programming resources as required to support project / study resource requirements.   Conduct performance reviews to develop and maintain competent and qualified staff.
  • Lead one or more projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval and post marketing support. Collaborate with statisticians and programmers across geographic locations to ensure high quality and timely statistical programming deliverables.
  • Assist resource assessments and project assignments based on in-depth project knowledge, milestones and deliverables.
Other Responsibilities
  • Other duties as assigned.
Education Requirement
  • Bachelor’s degree in Life Science, Statistics, Mathematics, or Computer Sciences is required.  Master’s degree preferred
Experience and Skills Requirements
  • Minimum of 12 years of SAS programming experience within a Pharma / Biotech or CRO
  • Managerial experience is required
  • Experience in working with CRO
  • Solid SAS programming skills and experience with CDISC, SDTM, ADaM and Pinnacle 21. Good programming skill in MACRO is needed
  • Experience in the analysis of complex oncology clinical trial data. Knowledge of immuno-oncology is a plus
  • Current NDA/BLA experience in creating DEFINE.XML, SDTMRG, ADAMRG
 
EEO & Employment Eligibility

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Recruitment/Staffing Agencies

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.

If you are interested in pursuing a career at Replimune, please complete the application.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.