Director/Sr. Director, Statistical Programming

Damora Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Damora Therapeutics, Inc. in Boston, MA seeks a Head of Statistical Programming to lead the programming function across its clinical portfolio. You will define strategy, manage internal staff and CROs, and ensure regulatory-ready programming deliverables.

The role requires extensive experience in SAS/R, CDISC, and ICH-GCP, with a track record of leading programming through NDA/BLA submissions and working cross-functionally with Biostatistics and Regulatory Affairs.

Qualifications

• Requires Bachelor’s degree in computer science, statistics, mathematics, data science, or analytics with 12+ years in biotech/pharma/CRO; or Master’s with 10+ years.
• Progressive leadership in statistical programming; experience leading a programming function or large team.
• Experience directing programming deliverables for regulatory submissions and working with CROs/vendors.
• Hands-on proficiency in SAS and R; familiarity with automation and open-source approaches.
• Strong knowledge of CDISC data standards and regulatory guidelines (ICH-GCP).
• Excellent communication skills and ability to influence at multiple levels.

Responsibilities

• Set vision and operating model for statistical programming across Damora clinical programs.
• Ensure on-time completion of programming deliverables with quality and compliance.
• Lead CRO/vendor programming teams and oversee external partnerships.
• Provide regulatory submission and inspection readiness input for programming deliverables.
• Manage resources, risk, and budget to meet business needs.
• Develop and mentor a high-performing programming team.

Skills

Leadership

SAS

R

CDISC

ICH-GCP

Regulatory submissions

Vendor management

Communication

Programming strategy

Education

Bachelor's degree in CS/Stats

Master's degree in related field

Tools

SAS

R

CDISC standards

Job description

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 capabilities, standards, and vendor partnerships that will carry these programs from first-in-human studies through registration.

Position Summary

The Head of Statistical Programming builds and leads the statistical programming function for Damora’s clinical development portfolio. Reporting to the Head of Biometrics, this leader sets the strategy and operating model for programming, provides functional and technical leadership, and is accountable for the quality, timeliness, and regulatory readiness of all programming deliverables. The role leads internal staff and CRO/vendor programming teams, and provides programming leadership to nonclinical, clinical pharmacology, and medical affairs studies as needed.

Key Responsibilities

Function Strategy and Leadership

• Set the vision, strategy, and operating model for statistical programming across all Damora clinical programs and the full compound lifecycle, ensuring consistency, efficiency, and quality of deliverables.
• Be accountable for the planning, execution, and on-time completion of all programming activities and deliverables, consistent with company quality and compliance standards.
• Serve as the company’s senior authority on statistical programming; stay current with industry trends, regulatory expectations, and emerging technologies, and drive adoption where they improve quality or efficiency.

Standards, Processes, and Systems

• Lead the development, review, and maintenance of statistical programming SOPs, processes, and standards (including CDISC conventions) in accordance with GCP and ICH guidelines.
• Provide leadership for the selection, validation, and evolution of the statistical computing environment and programming tools.

CRO and Vendor Oversight

• Define the outsourcing strategy for statistical programming, and oversee CRO programming teams and contractors, including selection, scope, performance, quality, and escalation.
• Ensure vendor deliverables meet Damora standards, are fully traceable, and are inspection ready.

Regulatory Strategy and Inspection Readiness

• Provide input on regulatory submission strategy and ensure all programming deliverables are complete and compliant, including those supporting health authority requests for information and data disclosure.
• Lead the programming aspects of regulatory inspections and internal audits, and maintain real-time inspection readiness for all programming deliverables.

Resources, Risk, and Cross-Functional Partnership

• Evaluate and manage resource demand, capacity, and budget (internal and external) to meet current and future business needs.
• Identify, prevent, and manage risks and issues affecting programming deliverables; lead program-level issue resolution and define escalation pathways.
• Partner with Biostatistics, Data Management, Clinical Development, Clinical Operations, and Regulatory Affairs to ensure integrated and timely delivery across programs.
• Build, lead, and develop a high-performing programming team, with responsibility for hiring; training and development; planning, assigning, and directing work; performance appraisal and recognition; and corrective action and complaint resolution.

Qualifications

Required

• Bachelor’s degree in computer science, statistics, mathematics, data science, or analytics with 12+ years of experience in the biotech, pharma, or CRO industry; or Master’s degree with 10+ years of experience.
• Progressive leadership experience in statistical programming, including leading a programming function or large programming team. Candidates at the Senior Director level will also have built a function, managed managers, and led programming through a marketing application (NDA/BLA/MAA) or equivalent.
• Prior people management experience, including hiring, developing, and managing programming staff and/or contractors.
• Hands-on proficiency in SAS and R, and familiarity with modern automation and open-source programming approaches.
• 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 directing programming deliverables for regulatory submissions and health authority interactions, and overseeing outsourced programming with CROs and other vendors.
• Proven leadership capabilities, including the ability to prioritize and resource effectively to drive results, apply sound judgment in complex situations, and influence and collaborate with others at multiple levels of the organization.
• Excellent written and oral communication skills and strong interpersonal skills, with a commitment to the success of others and total ownership and accountability for personal and functional performance.

Preferred

• Hematology/oncology drug development experience; myeloproliferative neoplasm (MPN) experience is a plus.
• Experience building or scaling a programming function and vendor model in a clinical-stage biotech.