Senior Director/Director, Biostats and Programming

Corbus Pharmaceuticals; United States; Hybrid; USD 150.000 - 200.000; Vollzeit

Benefits dieser Stelle

Innovative work environment

Collaborative team culture

Opportunity for professional growth

Zusammenfassung

A leading biotech firm in the United States is seeking a Senior Director/Director of Biostatistics and Programming. Responsibilities include strategic input into clinical development, CRO oversight, and provision of biostatistical expertise at regulatory meetings. The candidate should possess strong leadership and programming experience, specifically in oncology clinical trials. This hybrid role offers an engaging work environment and a chance to be part of a passionate team committed to innovative solutions in healthcare.

Qualifikationen

• 8+ years of biostatistics and/or programming experience.
• Deep understanding of CDISC standards (SDTM, ADaM) and submission requirements.
• Experience managing CRO programming teams.

Aufgaben

• Provide statistical input to trial design and operational oversight of biostatistical activities.
• Serve as the functional lead for all outsourced statistical programming activities.
• Ensure adherence to CDISC standards and regulatory compliance.

Kenntnisse

Biostatistics experience

Programming expertise

Leadership skills

Collaboration

Problem-solving

Ausbildung

Bachelor's degree in Statistics or related field

Tools

SAS Programming

Veeva

MedDRA

WHODrug

Jobbeschreibung

Senior Director/Director, Biostats and Programming

Direct message the job poster from Corbus Pharmaceuticals

Reporting to the Chief Medical Officer, the Senior Director/Director of Biostatistics and Programming will be responsible for strategic input to clinical development, providing input to trial design, and operational oversight of biostatistical activities at CROs. They will represent Corbus at meetings with regulatory agencies providing the necessary input for briefing books, meeting materials and other related documentation as required. Additionally, they will provide ad-hoc analysis to support internal/external presentations of data.

The ideal candidate has broad experience spanning biostatistics and programming. They will have experience overseeing CRO-delivered programming for early and late-stage trials and global submissions and bring strong leadership, technical acumen, and a collaborative mindset. This role requires close partnership with the Chief Operating Officer, Data Management, Clinical Operations, Regulatory, and external vendors to ensure high-quality, compliant, and timely programming deliverables. Experience in oncology clinical trial design is advantageous.

This role can be based hybrid to Norwood, Ma or remote with monthly travel to Norwood, Ma.

Primary Responsibilities

• Provide statistical input to trial design during clinical development planning, bringing to bear experience with adaptive designs and methodologies typically used in early & late phase oncology study.
• Provide subject matter expertise at regulatory meetings by attendance, and input in the preparatory materials such as briefing books.
• Provide input to Clinical Study Reports and Submissions including INDs, NDA/BLA/MAAs.
• Assist with ad-hoc analysis to support internal and external presentations including publications.
• Serve as the functional lead for all outsourced statistical programming activities across multiple clinical programs.
• Provide strategic oversight of CROs to ensure high-quality, consistent, and audit-ready programming deliverables.
• Review and approve CRO programming plans, timelines, resource strategies, and risk-mitigation approaches.
• Oversee and perform quality control (QC) review of CRO-produced datasets, tables, listings, and figures (TLFs) to ensure accuracy and regulatory compliance.
• Manage day-to-day CRO interactions, resolve technical issues, and ensure adherence to Corbus standards and expectations.
• Ensure deliverables support NDA/MAA submissions, including integrated summaries (ISS/ISE) and associated regulatory documentation.

Standards, Governance & Compliance

• Ensure adherence to CDISC standards (SDTM, ADaM, Define-XML), regulatory requirements, and internal quality expectations.
• Lead development, implementation, and maintenance of programming standards, SOPs, templates, and QC processes.
• Partner with Data Management to ensure high-quality data collection, CRF design, annotation, and documentation.
• Provide oversight for SDTM mapping, ADaM specification development, and traceability from raw data through final analyses.

Cross-Functional Leadership

• Support Clinical Study Reports (CSRs), data monitoring committees, and regulatory interactions.
• Provide expert guidance for exploratory analyses, post-hoc requests, and scientific presentations (programming may be required occasionally but is not the primary focus).
• Ensure strong communication flows between Corbus and external vendors to maintain alignment on priorities and quality expectations.

Qualifications

• Bachelor’s degree in Statistics or related field.
• 8+ years of biostatistics and/or programming experience, including extensive experience overseeing CRO programming teams.
• Proven track record supporting or leading statistical programming for early and pivotal Phase 3 trials and regulatory submissions (NDA/MAA/BLA).
• Deep understanding of CDISC standards (SDTM, ADaM) and FDA/EMA data submission requirements.
• Experience managing programming vendors, establishing governance frameworks, and ensuring high-quality outsourced deliverables.
• Strong knowledge of SAS programming concepts (hands‑on programming experience preferred, though oversight is the primary focus).
• Familiarity with clinical databases (e.g., Veeva is preferred) and medical coding dictionaries (MedDRA, WHODrug).
• Excellent collaboration, communication, leadership, and problem‑solving skills.
• Knowledge of AI/ML approaches is a plus.

About Corbus

Corbus is a close-knit global team of high-achieving, innovative, creative, and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody‑drug conjugate (ADC) that targets the expression of Nectin‑4 on cancer cells to release a cytotoxic payload, and CRB-601, an anti‑integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells. Additionally, we are developing a cannabinoid receptor‑1 (CB‑1) inverse agonist as a potential treatment for obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn, and Facebook.

Seniority Level

• Director

Employment Type

• Full‑time

Job Function

• Science

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.