Senior/Principal Statistical Programmer

The successful candidate will be responsible for supporting the statistical programming efforts for specific projects and studies including developing, testing, maintaining, validating and documenting SAS programs.  As part of the Statistical Programming team, the Senior/Principal Statistical Programmer will also provide technical expertise to the development of SAS macros or programming tools/utilities.

 

RESPONSIBILITIES

  • Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
  • Generate, validate, and/or review SDTM domains and ADaM datasets based on specifications
  • Maintain complete and auditable documentation of all programming activities
  • Review datasets and output across SAS programs and studies to ensure consistency
  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
  • Participate in the development and/or maintenance of departmental procedures and standards
  • Adhere to departmental and regulatory agency procedures and standards
  • Review CRFs, edit check specifications, and table, figure, and listing mock-ups
  • Work effectively with cross functional groups, study team, and vendors
  • Participate in monitoring CRO activities and reviewing CRO deliverables as necessary

 

REQUIREMENTS

  • Bachelor’s degree or higher in Statistics, Mathematics, or Computer Science or in a related field
  • 5+ years (senior statistical programmer)  or 7+ years (principal statistical programmer) Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
  • Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/GRAPH, SAS/SQL and SAS/ODS
  • Extensive knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational skills, time management, and ability to meet established deadlines
  • Excellent communication and interpersonal skills to effectively interface with others
  • Excellent organization and multi-tasking skills
  • Exceptional interpersonal skills and problem solving capabilities

 

COMPANY OVERVIEW

Jounce Therapeutics is an immuno-oncology company dedicated to transforming the treatment of cancer. The company is discovering and developing novel cancer immunotherapies designed to harness the immune system to attack tumors and provide long-lasting benefits to patients. Jounce integrates translational science insights including identification of related biomarkers designed to match the right immunotherapy to the right patients. The company is advancing programs that leverage contributions from its world-class founders as well as knowledge acquired from Jounce’s Translational Science Platform to create a sustainable “discovery to human proof-of-concept” product engine with the potential to drive significantly more durable responses to treatment. Founded by world leaders in tumor immunology, cancer biology and clinical and translational medicine, Jounce Therapeutics was launched in 2013 with funding from leading life sciences investor, Third Rock Ventures.  In July, 2013 Jounce entered into a strategic partnership with Celgene Corporation to Develop Next-generation Immuno-oncology Therapies for patients with cancer.