Senior Director/Director, Biostats and Programming at Corbus Pharmaceuticals Inc

Norwood, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Programming, CRO Oversight, Vendor Management, Regulatory Submissions, CDISC Standards, SAS Programming, Oncology Clinical Trials, Data Management, Quality Control, Statistical Analysis, Leadership, Collaboration, Problem-Solving, Adaptive Designs, Medical Coding

Industry

Pharmaceutical Manufacturing

Description

Description 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 hybrid to Norwood, Ma or remote with monthly travel to Norwood, Ma. Primary Responsibilities Clinical Development & Strategy 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. CRO Oversight & Vendor Management 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. Requirements 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. Corbus Culture: 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. About Corbus: 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, and anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells. Additionally, we are developing a cannabinoid receptor-1 (CB-1) inverse agonist as potential treatment for obesity. Corbus is headquarters in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Responsibilities

The Senior Director/Director of Biostatistics and Programming will provide strategic input to clinical development and oversee biostatistical activities at CROs. They will also represent the company at regulatory meetings and ensure high-quality programming deliverables.