Senior Manager, Statistical Programming
Dyne Therapeutics
4 months ago
Remote friendly (Waltham, MA)
United States
$143,000 - $175,000 USD yearly
Clinical Research and Development
Primary Responsibilities:
- Lead statistical programming for assigned clinical studies, with end-to-end accountability for study-level deliverables, quality, timelines, and compliance with regulatory requirements and internal standards
- Oversee and coordinate FSP vendor-based statistical programming resources (task assignments, progress tracking, issue escalation, quality oversight)
- Plan, manage, and monitor project timelines and deliverables to ensure on-time, high-quality execution and escalate risks as appropriate
- Collaborate with biostatisticians, data managers, and cross-functional teams to define and execute programming activities and study-specific requirements
- Develop, validate, and maintain CDISC-compliant analysis datasets (SDTM, ADaM) and TLFs (tables, listings, figures)
- Review and provide input on Statistical Analysis Plans (SAPs) to ensure executable assumptions, derivations, and outputs
- Perform or oversee complex SAS statistical programming and analyses to support clinical trial analyses and data interpretation
- Support regulatory submissions (e.g., FDA, EMA), including preparation of eCTD components, Define.xml, and reviewer guides
- Stay current with industry trends, best practices, and emerging technologies in statistical programming, data standards, and regulatory expectations
Qualifications / Education:
- Bachelor’s or advanced degree in statistics, biostatistics, computer science, or a related field
- 7+ years of experience in statistical programming in the pharmaceutical or biotech industry
Skills / Requirements:
- Proficiency in SAS (essential); R experience preferred
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
- Demonstrated leadership and project management skills; ability to collaborate cross-functionally
- Excellent written and verbal communication and interpersonal skills
- Detail-oriented with a commitment to data accuracy and quality
- Ability to adapt to changing priorities and manage multiple projects simultaneously
Compensation:
- MA Pay Range: $143,000 - $175,000 USD
- Lead statistical programming for assigned clinical studies, with end-to-end accountability for study-level deliverables, quality, timelines, and compliance with regulatory requirements and internal standards
- Oversee and coordinate FSP vendor-based statistical programming resources (task assignments, progress tracking, issue escalation, quality oversight)
- Plan, manage, and monitor project timelines and deliverables to ensure on-time, high-quality execution and escalate risks as appropriate
- Collaborate with biostatisticians, data managers, and cross-functional teams to define and execute programming activities and study-specific requirements
- Develop, validate, and maintain CDISC-compliant analysis datasets (SDTM, ADaM) and TLFs (tables, listings, figures)
- Review and provide input on Statistical Analysis Plans (SAPs) to ensure executable assumptions, derivations, and outputs
- Perform or oversee complex SAS statistical programming and analyses to support clinical trial analyses and data interpretation
- Support regulatory submissions (e.g., FDA, EMA), including preparation of eCTD components, Define.xml, and reviewer guides
- Stay current with industry trends, best practices, and emerging technologies in statistical programming, data standards, and regulatory expectations
Qualifications / Education:
- Bachelor’s or advanced degree in statistics, biostatistics, computer science, or a related field
- 7+ years of experience in statistical programming in the pharmaceutical or biotech industry
Skills / Requirements:
- Proficiency in SAS (essential); R experience preferred
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
- Demonstrated leadership and project management skills; ability to collaborate cross-functionally
- Excellent written and verbal communication and interpersonal skills
- Detail-oriented with a commitment to data accuracy and quality
- Ability to adapt to changing priorities and manage multiple projects simultaneously
Compensation:
- MA Pay Range: $143,000 - $175,000 USD