Director/Sr Director, Biostatistics

Description

Director / Senior Director, Biostatistics

About Company:

Clinical-stage biopharmaceutical company pioneering mRNA-engineered CAR-T cell therapies for severe autoimmune diseases. Our lead asset, Descartes-08, an anti-BCMA autologous mRNA CAR-T therapy, has received RMAT designation for generalized myasthenia gravis (gMG) and is currently being evaluated across a portfolio of clinical programs:

• AURORA — Phase 3 randomized, double-blind, placebo-controlled trial in gMG

• TRITON — Phase 2 randomized controlled trial in dermatomyositis and antisynthetase syndrome

• HELIOS — Phase 1/2 trial in juvenile dermatomyositis

• Planned in vivo CAR-T program in the United States — early-stage strategic development

We are a data-driven organization committed to rigorous clinical science, regulatory excellence, and rapid translation of breakthrough therapies to patients with limited treatment options.

Position Summary:

Seeking an experienced and strategically minded Director or Senior Director of Biostatistics to join our Clinical Development team. This is a Senior individual contributor and people-management role with significant influence across all active clinical programs. Reporting to the Vice President of Clinical Development, this position provides statistical leadership from protocol design through data analysis, regulatory submission, and post-marketing planning.

The successful candidate will serve as the internal statistical authority for company's portfolio, interface directly with regulatory agencies, oversee external statistical resources, and help shape the analytical strategy for our emerging in vivo CAR-T program. This role requires both technical depth and the ability to communicate complex statistical concepts clearly to clinical, regulatory, and executive stakeholders.

Key Responsibilities:

Phase 3 Program Support — AURORA (Myasthenia Gravis)

• This study is being conducted in partnership with a full service CRO which will be responsible for data analysis and CRS generation. The major responsibility will be to oversee and interact with the CRO data management and statistical group to ensure accuracy of final outputs.

• Lead or contribute to protocol amendments and statistical analysis plan (SAP) amendments as the study evolves, ensuring alignment with FDA SPA agreements and RMAT designation commitments

• Review and approve TLF (tables, listings, figures) shells generated by CRO to ensure consistency with the SAP, regulatory expectations, and clinical data review needs

• Serve as the primary internal statistical point of contact for DSMB support

Phase 2 Program Support — TRITON (Dermatomyositis/Antisynthetase Syndrome)

• This study is being conducted solely by company.

• Develop and finalize protocol amendments as the program matures, including revisions to objectives, endpoints, estimands, and statistical methodologies

• Author and maintain the SAP, including specification of primary and secondary analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses

• Design and implement the interim analysis plan, including interim sample size evaluation and pre-specified stopping boundaries

• Provide ongoing DSMB statistical support

Phase 1/2 Program Support — HELIOS (Juvenile DM)

• Contribute to protocol amendments, including updates to safety monitoring frameworks, dose escalation rules, and preliminary efficacy evaluations in the pediatric population

• Support Safety Monitoring Committee (SMC) operations with appropriate statistical summaries and ad hoc analyses

In Vivo CAR-T Program — Strategic Planning

• Partner with Clinical Development to define the statistical and clinical trial design strategy for company's planned in vivo CAR-T program in the United States

• Advise on Phase 1/2 study design, dose escalation frameworks, estimand strategy, and adaptive design considerations

• Contribute to pre-IND and Type B meeting packages as relevant statistical support

Data Management Operations Oversight:

• Collaborate closely with the external data management vendor to ensure timely, high-quality clinical trial data delivery and database integrity.

• Provide statistical oversight and partnership to contract data management teams for CRF design, edit checks, data review, query management, and database lock activities.

• Work cross-functionally with Clinical Operations, Data Management, Statistical Programming, and external vendors to support efficient and compliant clinical data workflows.

• Participate in data review meetings with CROs and vendors to ensure consistency, quality, and readiness of clinical datasets for analysis and reporting.

External Statistical Resource Management:

• Select, manage, and evaluate consulting biostatisticians and statistical programming vendors engaged across company's pipeline

• Serve as the primary interface with CRO statisticians: review statistical deliverables, provide clear direction on analytical methodology, and ensure CRO outputs meet company's standards

Regulatory and Cross-Functional Contributions:

• Contribute to regulatory submissions and briefing documents requiring statistical input, including Type B/C meeting packages, SPA requests, IND amendments, and BLA preparation

• Participate in FDA statistical discussions; prepare and defend analytical approaches in regulatory interactions

• Collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs, and CMC to ensure integrated, coherent data strategies across programs

Additional Skills & Qualifications

Education:

• Ph.D. in Biostatistics, Statistics, or a closely related field preferred

• Master’s degree in Biostatistics or Statistics required; candidates with a Master’s degree must have 5-10 years of relevant industry experience to be considered at the Director level

Experience:

• Ph.D. candidates: minimum 5 years of pharmaceutical/biotech industry experience, including experience leading statistical activities on at least one Phase 2 or Phase 3 clinical trial

• Master’s candidates: at least 10 years of pharmaceutical/biotech industry experience preferred with demonstrated progression to Senior statistical leadership roles

• Direct experience authoring or reviewing SAPs for randomized controlled trials required; Phase 3 SAP experience strongly preferred

• Experience supporting DSMB or Data Safety Committees

• Demonstrated experience managing or directing CRO statisticians and/or external statistical consultants

• Familiarity with CDISC standards (SDTM, ADaM) and regulatory expectations for submission-ready datasets

• Prior experience contributing to FDA regulatory submissions (IND amendments, meeting packages, BLA/NDA modules) is strongly preferred

Technical Competencies:

• Expert proficiency in SAS; R or Python experience valued

• Working knowledge of clinical trial design methods including adaptive designs, group sequential methods, and Bayesian approaches

• Experience with mixed-effects models, repeated measures analyses, and handling of missing data (multiple imputation, sensitivity analyses) in the context of chronic disease clinical trials

• Familiarity with estimand framework (ICH E9(R1)) and its application to protocol and SAP development

Leadership and Interpersonal Skills:

• Ability to operate effectively as both a strategic thought partner and hands-on technical contributor in a small company environment

• Strong written and verbal communication skills; able to translate statistical concepts for clinical, regulatory, and executive audiences

This is a Permanent position based out of Gaithersburg, MD.

The pay range for this position is $230000.00 - $295000.00/yr.

Company Benefits Company Benefits

This is a hybrid position in Gaithersburg,MD.

This position is anticipated to close on Jul 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $230,000 - $295,000