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Bicycle Therapeutics




+30d

Associate Director, Statistical Programming

Bicycle TherapeuticsCambridge, MA, Remote

Bicycle Therapeutics is hiring a Remote Associate Director, Statistical Programming

Job Description

The Associate Director, Statistical Programming will be accountable and responsible for leading statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring timely deliverables with high quality. You also will perform oversight on the counterpart from vendors. You will report to Senior Director, Statistical Programming.

You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in Oncology therapeutic area.

  • Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming support
  • Develop and validate programming specification for table, listing, and figure
  • Develop and validate SAS program that generate table, listing, and figure
  • Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specification
  • Develop and validate SAS program that generate SDTM and ADaM dataset
  • Create and validate files necessary to support electronic submission in eCTD format
  • Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publication
  • Support development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function

Qualifications

Essential:  

  • Good Clinical Practice (GCP) proficient
  • Broad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in Oncology therapeutic area
  • Proficient programming skills using SAS. In-depth experience on BASE SAS, SAS/STAT, SAS Macro
  • Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit
  • Excellent communication skills, both written and verbal

Desirable:  

Proficient in R programming  

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