Senior Statistical Programmer (CDISC SDTM/ADaM)

DBV Technologies; New Jersey; On-site; USD 130,000 - 190,000; Full time

Job summary

DBV Technologies is seeking a senior biostatistics professional to support clinical studies with dual expertise in statistical programming aligned to CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes producing, validating, and reviewing CDISC deliverables and executing statistical analyses.

The ideal candidate holds a MSc/PhD in Biostatistics or a related field with 6–8 years of CDISC programming experience, plus SAS proficiency and Pinnacle 21 knowledge for regulatory

Qualifications

• Master's degree or PhD in Biostatistics, Statistics, Mathematics, or related field.
• 6–8 years of statistical programming experience for clinical trials with CDISC SDTM/ADaM.
• Experience with regulatory submissions and CRO management is desirable.

Responsibilities

• Participate in the design of clinical studies with biostatisticians.
• Write and review Statistical Analysis Plans (SAPs).
• Program and validate SDTM and ADaM datasets.
• Produce and review SDTM/ADaM deliverables and TLFs.
• Ensure regulatory compliance using Pinnacle 21.
• Contribute to regulatory submission packages and Define.xml.
• Perform QC activities and collaborate with clinical/regulatory teams.

Skills

Statistical programming

CDISC SDTM/ADaM

Clinical statistics

Education

Master's degree in Biostatistics or related field

PhD or MSc in Biostatistics/Statistics/Mathematics

Tools

SAS (Base SAS, SAS Studio, SAS Viya)

Pinnacle 21

Job description

Job Description

Provide support for clinical studies through dual expertise in statistical programming compliant with CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes the production, validation, and review of CDISC deliverables, as well as the execution and support of statistical analyses.

Responsibilities

• Participate in the design of clinical studies in collaboration with biostatisticians.
• Contribute to the writing and review of Statistical Analysis Plans (SAPs).
• Program and validate SDTM and ADaM datasets.
• Produce, validate, and review SDTM/ADaM deliverables (annotated CRFs, specifications, datasets).
• Ensure regulatory compliance using Pinnacle 21.
• Participate in and validate regulatory submission deliverables (Define.xml, submission packages).
• Perform Quality Control (QC) activities.
• Produce and validate Tables, Listings, and Figures (TLFs).
• Collaborate closely with clinical and regulatory teams.

Profile

• Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or a related field (e.g., ENSAI or equivalent).
• Minimum of 6–8 years of experience in statistical programming for clinical trials, with strong expertise in CDISC standards (SDTM/ADaM).
• Experience with regulatory submissions and CRO management is highly desirable.

Technical Skills

• Proficiency in SAS (Base SAS, SAS Studio, SAS Viya).
• Strong expertise in CDISC SDTM and ADaM standards.
• Good knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements.
• Experience using Pinnacle 21.
• Solid understanding of clinical statistics.
• Fluent English (written and spoken).

Behavioral Competencies

Curiosity

Continue exploring new horizons. Constantly ask "Why?" and, more importantly, "Why not?".

Courage

Take smart risks and support one another in continuously improving. Push boundaries, turn challenges into opportunities, and take ownership of our decisions, opinions, and actions.

Collaboration

Learn from one another. Grow and develop as a multicultural, international team working toward shared goals.

Credibility

Strive for excellence in everything we do. Transparency and expertise are the foundation of our relationships with patients, partners, and shareholders. Data and results are at the heart of our commitment.

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively.

We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.

This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.

Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.

Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.