Associate Director, Statistical Programming

Damora Therapeutics; Waltham (MA); In loco; USD 180.000 - 230.000; Tempo pieno

Descrizione del lavoro

Damora Therapeutics, Inc. is seeking an Associate Director of Statistical Programming to lead programming for one or more clinical programs in a fast-growing biotech setting.

This role ensures quality, timelines, and regulatory compliance of all programming deliverables from study start-up through submission. You will provide hands-on technical leadership, oversee CRO teams, and help implement standards and innovative solutions to improve efficiency and data quality.

Competenze

• MS or higher in computer science, statistics, data science, or analytics with 6+ years in biotech/pharma; or BS with 8+ years.
• Demonstrated hands-on proficiency in SAS and R; experience with CDISC data standards and regulatory guidelines (ICH-GCP).
• Experience planning and coordinating complex programming strategy and overseeing outsourced programming with CROs.

Mansioni

• Lead programming activities and deliverables across assigned clinical programs; ensure high quality and on-time delivery.
• Oversee CROs/contractors; manage workload, quality, timelines, and budget; escalate issues as needed.
• Develop and implement programming standards and innovative solutions to improve efficiency and inspection readiness.

Conoscenze

Leadership

Project management

Mentoring

Communication

Formazione

MS or higher in computer science / statistics / data science or analytics

BS with 8+ years in biotech/pharma

Strumenti

SAS

R

CDISC standards

Descrizione del lavoro

Damora Therapeutics, Inc. (Nasdaq: DMRA) is a Boston-based biotechnology company working to fundamentally redefine care for patients with blood disorders. Damora is advancing a new generation of subcutaneous biologics targeting mutant calreticulin (mutCALR)-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis - chronic hematologic cancers with significant unmet need. The company’s lead program, DMR-001, is an investigational monoclonal antibody designed to selectively target mutant calreticulin, with additional programs (DMR-002 and DMR-003) advancing behind it.

As DMR-001 advances through clinical development and additional programs follow, Damora is building the biometrics team and standards needed to deliver high-quality, inspection-ready data across its pipeline.

Position Summary

The Associate Director, Statistical Programming serves as the programming lead for one or more Damora clinical programs and is accountable for the quality, timelines, and regulatory compliance of programming deliverables from study start-up through submission. The Associate Director provides hands-on technical leadership and day-to-day oversight of CRO and contractor programming teams, and helps implement and improve programming strategy, processes, and standards. The role represents statistical programming on project teams and supports safety reporting, nonclinical, and CMC studies as needed.

Key Responsibilities

Program Leadership and Delivery

• Serve as the statistical programming lead for assigned programs and studies; plan, execute, and complete all programming activities and deliverables on time and with high quality, consistent with departmental and company quality and compliance standards.
• Develop and drive programming strategy for assigned compounds across the program life cycle to ensure consistency, efficiency, and quality of deliverables.
• Represent statistical programming on project and study teams, communicating timelines, status, risks, and dependencies.
• Review and approve key programming deliverables, including specifications, SDTM and ADaM datasets, define.xml, tables, listings and figures, and reviewer's guides.

CRO and Contractor Oversight

• Oversee the day-to-day work of programming CROs and contractors, including assigning work, reviewing deliverables, and monitoring quality, timelines, and budget; escalating issues to functional leadership as needed.

Standards, Processes, and Innovation

• Develop, maintain, and implement statistical programming processes and standards in accordance with GCP and ICH guidelines to enable efficient and consistent programming activities.
• Serve as a statistical programming expert; stay current with industry trends and policies, and develop and implement innovative technical solutions that improve efficiency and quality.

Regulatory and Inspection Readiness

• In collaboration with the Biostatistics lead and other functions, provide input to submission strategy and ensure all programming deliverables are complete and compliant, including those supporting health authority requests for information and data disclosure.
• Lead programming aspects of regulatory inspections and internal audits, and maintain real-time inspection readiness for all programming deliverables.

Resources, Risk, and Team Development

• Evaluate resource demand and allocation for assigned programs to meet current and future business needs and ensure effective utilization.
• Identify, prevent, and manage risks and issues affecting programming deliverables; lead program-level issue resolution and adjust appropriately.
• Mentor and provide technical guidance to programmers and contractors; manage direct reports as the team grows.

Qualifications

Required

• M.S. or higher degree in computer science, statistics, mathematics, data science, or analytics with 6+ years of experience in the biotech or pharma industry; or B.S. with 8+ years of experience.
• In-depth knowledge of programming practices and concepts (tools, languages, and processes), CDISC data standards, and relevant regulatory guidelines (e.g., ICH-GCP).
• Demonstrated experience planning and coordinating complex programming strategy and delivery, and managing and overseeing statistical programming activities, including outsourced programming with CROs in the clinical trial setting.
• Demonstrated hands-on proficiency in SAS and R, and experience developing and supporting innovative technical solutions that enhance efficiency and/or quality.
• Proven leadership capabilities, including the ability to prioritize and resource effectively to drive results, apply sound judgment in complex situations, and influence and work effectively with others at multiple levels of the organization.
• Excellent written and oral communication skills and strong interpersonal skills, with a proven track record of commitment to the success of others and total ownership and accountability for personal and functional performance.

Preferred

• Later-stage clinical trial experience, NDA/BLA submissions, and experience with FDA and ex-US regulatory authorities are highly desired.
• Experience supporting early-phase dose-escalation and adaptive trial designs.