Search jobs > Boston, MA > Director programming

Associate Director Statistical Programming

Aura BioSearch
Boston, Massachusetts, United States
Full-time

Assocuate Director, Statistical Programming

We're seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical development programs and manage vendor oversight.

This role will collaborate closely with biostatisticians, data managers, and cross-functional teams, and will be an in-house expert in programming and data standards.

Key Responsibilities :

  • Lead and manage programming for clinical trials, ensuring quality and adherence to timelines.
  • Collaborate on programming strategies and support regulatory submissions.
  • Develop and maintain analysis datasets, tables, and figures following CDISC standards.
  • Provide technical guidance to cross functional teams and vendors.
  • Stay current with industry trends and introduce innovative solutions.

Requirements :

  • MS in Statistics, Computer Science, Life Sciences or related field with 8+ years of experience in statistical programming.
  • Expert in SAS programming and macro development.
  • Familiarity with ICH guidelines, CDISC standards, and regulatory requirements. Oncology experience preferred.
  • Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
  • Experience in NDA / BLA or other regulatory filings.
  • Strong communication, and organizational skills.
  • 1 day ago
Related jobs
Promoted
Aura BioSearch
Boston, Massachusetts

Director Statistical Programming. Director of Statistical Programming. This role will collaborate closely with biostatisticians data managers and crossfunctional teams and will be an inhouse expert in programming and data standards. Lead and manage programming for clinical trials ensuring quality an...

Promoted
Xenon Pharmaceuticals Inc.
Boston, Massachusetts

Associate Director/Director, Clinical Programming & Data Standards. Associate Director/Director, Clinical Programming & Data Standards. As an Associate Director/Director of Clinical Programing and Data Standards, you will be required to program in the appropriate languages to create both textual and...

Promoted
Atlas Venture
Waltham, Massachusetts

The Director, Statistical Programming is accountable for in-house statistical programming activities and oversight related activities by vendors for assigned clinical development programs. This role assists the Senior Director, Statistical Programming to develop functional strategies and drives the ...

Servier
Boston, Massachusetts

Develop statistical programming on study or project level either by hands-on programming or oversight of outsourced programming deliverables. Ensure statistical programming processes and deliverables are aligned with regulatory requirements. Act as technical lead and project manager for multiple stu...

Dyne Therapeutics
Waltham, Massachusetts

The Associate Director, Statistical Programming is accountable for program specific statistical programming activities and oversight related activities by vendors in clinical development, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverab...

Aura BioSearch
Boston, Massachusetts

Assocuate Director, Statistical Programming. Director of Statistical Programming. MS in Statistics, Computer Science, Life Sciences or related field with 8+ years of experience in statistical programming. This role will collaborate closely with biostatisticians, data managers, and cross-functio...

AstraZeneca
Boston, Massachusetts

Our teams use their expertise in statistics and programming to address drug development objectives and reduce uncertainty in product development, driving better business decisions with quantitative reasoning. Take a leadership role and drive statistical thinking in cross-functional team projects, wi...

Boston College Carroll School of Manageme
Newton, Massachusetts

Associate Director, Intercultural Programming. Associate Director, Intercultural Programming. The Associate Director will work collaboratively with the Director to provide leadership in carrying out the programmatic and operational functions of the Bowman Center. In addition, the Associate Director ...

Aura BioSearch
Boston, Massachusetts

Director Statistical Programming. Director of Statistical Programming. This role will collaborate closely with biostatisticians data managers and crossfunctional teams and will be an inhouse expert in programming and data standards. Lead and manage programming for clinical trials ensuring quality an...

Takeda Pharmaceuticals North America, Inc.
Lexington, Massachusetts

Required skills: Oversee and manage statistical SAS programming activities to support clinical studies and submission across multiple protocols; Create/review SDTM/ADaM specification and datasets to follow CDISC standard and create/oversight statistical output for clinical studies; Improve the proce...