Senior Director, Biostatistics- Medical Affairs & Commercial Support

Description :

Reporting to the Vice President, Biostatistics, the Senior Director of Biostatistics will serve as the dedicated statistical lead supporting DBV's Medical Affairs and emerging Commercial organizations as the company advances VIASKIN® Peanut through BLA submission and prepares for U.S. commercial launch. While based within the Biometrics function — ensuring direct access to analysis datasets, consistency with regulatory analyses, and shared statistical standards — this role's mandate and customers sit outside it: Medical Affairs, Medical Information, and Commercial. A dotted-line relationship to the Head of Medical Affairs (or CMO) formalizes that accountability.

The role owns the statistical dimension of DBV's externally facing medical and commercial evidence work: generating the post-hoc, subgroup, integrated, and descriptive analyses Medical Affairs needs for scientific exchange and launch readiness; serving as the statistical authority behind Medical Information deliverables; providing statistical support to publications and congress activity led by Medical Affairs colleagues; and — critically — owning statistical substantiation of approved, branded messaging as DBV builds its first promotional review infrastructure. This is deliberately not a trial-execution role: SAPs, CSRs, and BLA analyses remain with the broader Biometrics team and CRO partners. The role exists so that launch-critical medical and commercial analytics are not competing with regulatory deliverables for the same statistician.

In a first-in-class category (epicutaneous immunotherapy) with a pediatric population and no comparator precedent, the line between what the data shows and what the organization wants to say will be tested constantly. Sitting in Biometrics gives this leader the institutional independence to hold that line in medical/legal/regulatory (MLR) review and claims-development settings, while day-to-day embedding with Medical and Commercial ensures they help those teams find the strongest messages the evidence genuinely supports.

The successful candidate will have done this before: supported publications and congress activity as the statistician, fielded the statistical side of medical information, and worked shoulder-to-shoulder with a commercial organization through a launch — turning pivotal-trial data into claims grids, substantiation packages, and launch materials that survived legal, regulatory, and competitive scrutiny. They will operate hands-on in a lean environment, often as the only statistician in the room.

Location : Warren, New Jersey - minimum 3 days on site, with domestic and occasional international travel as required (congresses; coordination with Châtillon, France HQ).

Salary Range : $240-280k

Key Responsibilities :

• Serve as the dedicated statistical lead for Medical Affairs and Commercial: define and execute the medical analytics plan supporting scientific exchange, medical strategy, and launch readiness for VIASKIN Peanut, under the statistical standards of the Biometrics function.

• Design and conduct post-hoc, subgroup, integrated, and descriptive analyses from EPITOPE, VITESSE, open-label extensions, and supporting studies in response to Medical Affairs and Commercial evidence needs — within regulatory and legal guardrails.

• Own statistical substantiation for branded and promotional messaging: partner with Commercial, Regulatory, and Legal in claims development, maintain the data support behind the claims matrix, and serve as statistical reviewer in the MLR process as DBV stands up its first commercial review infrastructure.

• Provide the statistical foundation for Medical Information: data-on-file analyses, statistical content of standard response documents, and support for responses to unsolicited HCP requests pre- and post-launch.

• Provide statistical support to publications and congress activity led by Medical Affairs colleagues — analyses, statistical methods sections, reviewer-response support — without owning the publication plan itself.

• Brief and support MSLs and medical directors on the statistical story of the data: what the endpoints mean, where the evidence is strong, where it is limited, and how to discuss both credibly with KOLs.

• Partner with HEOR/market access on analyses supporting value communication, recognizing that the absence of an EPIT formulary comparator set requires value-based evidence anchoring.

• Ensure consistency between Medical Affairs/Commercial analyses and regulatory analyses: shared datasets, aligned derivations, and a single source of truth for every externally stated number, in coordination with Biometrics colleagues and CRO partners.

• Represent Biometrics in cross-functional launch-readiness forums, translating statistical considerations into commercial and medical planning decisions.

• Scale the capability toward launch: manage statistical programming support (internal or vendor), set standards for medical-affairs and promotional analytics within the Biometrics quality framework, and extend support to lifecycle programs (milk patch, EoE) as they mature.

Qualifications :

• PhD or MS in Biostatistics, Statistics, or a closely related quantitative field.

• 12–15+ years in biopharmaceutical biostatistics, including substantial dedicated support of Medical Affairs and/or Commercial (not exclusively regulatory/trial-execution statistics).

• Demonstrated experience as the supporting statistician for peer-reviewed publications, congress abstracts/presentations, and medical information deliverables (standard response documents, data-on-file analyses).

• Direct experience supporting a commercial launch: claims development and substantiation, MLR/promotional review participation, and statistical support of branded/approved messaging.

• Working knowledge of the regulatory and compliance framework governing promotional claims and scientific exchange (substantiation standards, fair balance, pre-approval communication boundaries).

• Experience in a lean or mid-size biotech, or demonstrated readiness to move from large pharma infrastructure to a hands-on, build-it-yourself environment.

• Immunology, allergy, or pediatric therapeutic area experience strongly preferred; first-in-class or novel-mechanism launch experience valued given EPIT has no category precedent.

• Ability to communicate statistical nuance credibly to non-statistical audiences — commercial leaders, medical reviewers, KOLs, executives — and to disagree constructively when a desired claim outruns the evidence.

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.