Associate Director, Statistical Programming
Immunome, Inc.
3 months ago
Remote friendly (New Bern-Morehead City Area)
United States
Clinical Research and Development
Responsibilities:
- Lead statistical programming activities for 1–2 clinical studies, ensuring high-quality deliverables across the study lifecycle.
- Create programming specifications from the Statistical Analysis Plan; oversee SDTM/ADaM creation, validation, and delivery, including TLFs, Define.xml, and reviewer’s guides.
- Provide hands-on SAS support for key analyses and data exploration; support internal/regulatory deliverables.
- Manage programming timelines and dependencies; align with cross-functional study plans and milestones.
- Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety to review requirements, refine specs, and resolve data/programming issues.
- Review Data Management Plans, case report forms, data transfer specifications, and validation plans for downstream readiness.
- Oversee CRO statistical programming; review outputs for accuracy/compliance and ensure timely, high-quality datasets and results.
- Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using tools (e.g., Pinnacle 21).
- Develop/maintain SAS macros, utilities, and programming tools to improve efficiency and scalability.
- Ensure adherence to CDISC standards, FDA/regulatory expectations, departmental SOPs, and data traceability best practices.
- Mentor junior programmers/contractors; contribute to process improvements and cross-functional projects.
Qualifications:
- Master’s degree (or higher) in Statistics, Computer Science, or related field, plus 8+ years of pharmaceutical/biotech industry experience.
- Solid knowledge of statistical programming, clinical trials processes, and regulatory requirements.
- Prior NDA submission and regulatory agency interaction experience (highly desirable).
- Oncology/Hematology experience (highly desirable).
Knowledge/Skills:
- Strong SAS programming and technical skills; knowledge of CDISC standards (SDTM, CDASH, ADaM) and related data standards.
- Strong problem-solving and risk-mitigation skills.
- Excellent verbal/written and interpersonal communication skills across cross-functional teams.
- Working knowledge of ICH, FDA, and GCP.
- Must be located on the US West Coast Time Zone.
- Lead statistical programming activities for 1–2 clinical studies, ensuring high-quality deliverables across the study lifecycle.
- Create programming specifications from the Statistical Analysis Plan; oversee SDTM/ADaM creation, validation, and delivery, including TLFs, Define.xml, and reviewer’s guides.
- Provide hands-on SAS support for key analyses and data exploration; support internal/regulatory deliverables.
- Manage programming timelines and dependencies; align with cross-functional study plans and milestones.
- Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety to review requirements, refine specs, and resolve data/programming issues.
- Review Data Management Plans, case report forms, data transfer specifications, and validation plans for downstream readiness.
- Oversee CRO statistical programming; review outputs for accuracy/compliance and ensure timely, high-quality datasets and results.
- Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using tools (e.g., Pinnacle 21).
- Develop/maintain SAS macros, utilities, and programming tools to improve efficiency and scalability.
- Ensure adherence to CDISC standards, FDA/regulatory expectations, departmental SOPs, and data traceability best practices.
- Mentor junior programmers/contractors; contribute to process improvements and cross-functional projects.
Qualifications:
- Master’s degree (or higher) in Statistics, Computer Science, or related field, plus 8+ years of pharmaceutical/biotech industry experience.
- Solid knowledge of statistical programming, clinical trials processes, and regulatory requirements.
- Prior NDA submission and regulatory agency interaction experience (highly desirable).
- Oncology/Hematology experience (highly desirable).
Knowledge/Skills:
- Strong SAS programming and technical skills; knowledge of CDISC standards (SDTM, CDASH, ADaM) and related data standards.
- Strong problem-solving and risk-mitigation skills.
- Excellent verbal/written and interpersonal communication skills across cross-functional teams.
- Working knowledge of ICH, FDA, and GCP.
- Must be located on the US West Coast Time Zone.