Senior Director, Biostatistics, Clinical Operations

Asklepios BioPharmaceutical, Inc. (AskBio)

. Provide technical leadership and operational oversight for clinical strategies and the design, implementation, and reporting of non-clinical, CMC, and clinical development programs, studies, and trials .

Posted 10/5/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics, clinical trial design, and regulatory submissions, with a strong focus on statistical analysis and leadership in pharmaceutical development. Proven ability to manage resources, collaborate with cross-functional teams, and provide strategic guidance to senior leadership.

Highest-signal resume keywords

Ph.D. Or M.S. In Statistics10+ Years Pharmaceutical ExperienceExtensive Experience With SAS And/Or RClinical Trial Design ConceptsExperience With Adaptive And Bayesian Study Design

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsStatistical Analysis PlansData AnalysisClinical Trial DesignDesign Of ExperimentsRegulatory SubmissionsStatistical Function ManagementStatistical TrainingEndpoint SelectionPower And Sample Size Assessments

Soft Skills

Excellent Communication SkillsLeadership SkillsInterpersonal SkillsAbility To Build Credibility And Trust

Tools & Technologies

SASR

Industry Keywords

PharmaceuticalBiotech R&DCRO ManagementNew Drug ApplicationsCardiovascular ProgramsMetabolic ProgramsKidney ProgramsCNS ProgramsRare Disease ProgramsGene Therapy

About the role

Key responsibilities & impact

Provide technical leadership and operational oversight for clinical strategies and the design, implementation, and reporting of non-clinical, CMC, and clinical development programs, studies, and trials
Perform peer review of clinical trial designs and reports for other biostatisticians
Provide guidance and management to statisticians, programmers, and data managers
Advise senior leadership and functional leads on biostatistics strategies and business-impacting issues
Oversee biostatistics functions at CROs and manage scopes of work and external statistical consultant relationships
Manage resources, set priorities, and ensure consistency with standards
Collaborate on protocol development, study design, endpoint selection, and power and sample size assessments
Lead statistical analysis plans, data analysis, and clinical study report content
Support Data Monitoring Committee charters and meeting preparation
Represent AskBio in interactions with the FDA, EMA, and other health authorities
Support regulatory submissions and interactions, including IND and BLA filings, and potential partnering requests
Provide statistical input to clinical development plans, protocols, investigator brochures, regulatory submissions and responses, publications, and presentations
Develop and communicate solutions to statistical and data analysis issues
Contribute to departmental SOPs, standardization efforts, and statistical training
Maintain current knowledge of statistics, drug development, and regulatory guidance
Participate in due diligence evaluations, business development activities, scientific and medical meetings, vendor management, and industry conferences

Requirements

What you’ll need

Ph.D. or M.S. in Statistics or a related field
10+ years of pharmaceutical experience in a pharmaceutical or biotech R&D environment
Knowledge of cardiovascular, metabolic, kidney, CNS, and/or rare disease programs
Previous experience preparing and submitting New Drug Applications to regulatory agencies
Strong knowledge of design of experiments, clinical trial design concepts or CMC statistics, drug regulation, and management of the statistical function
Extensive experience with SAS and/or R
Excellent communication skills
Experience in CRO selection, contracting, and management
Excellent leadership and interpersonal skills, with the ability to build credibility and trust inside and outside the Company
Experience with adaptive and Bayesian study design simulation techniques
Experience in rare diseases and/or gene therapy

Benefits

Comp & perks

Equal Opportunity Employer
Reasonable accommodation available for qualified individuals with a disability or disabled veteran