Senior Director, Biostatistics, Clinical Operations

AskBio Inc.

. 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 statistical analysis, clinical trial design, and regulatory submissions, with a strong focus on leadership and collaboration across clinical and commercial teams. Proficient in managing biostatistics functions and providing strategic guidance to ensure high-quality deliverables in a pharmaceutical or biotech environment.

Highest-signal resume keywords

Ph.D. Or M.S. In Statistics10+ Years Pharmaceutical ExperienceSAS And/or R ProficiencyClinical Trial Design ConceptsRegulatory Submissions Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Trial DesignDesign Of ExperimentsCMC StatisticsAdaptive Study DesignBayesian Study DesignData AnalysisStatistical Function ManagementStatistical TrainingProtocol Development

Soft Skills

Excellent Communication SkillsLeadership SkillsInterpersonal SkillsCredibility BuildingTrust Building

Tools & Technologies

SASR

Industry Keywords

PharmaceuticalBiotechRegulatory AgenciesNew Drug ApplicationsCRO ManagementCardiovascular ProgramsMetabolic 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 to ensure high-quality and timely deliverables
Advise senior leadership and functional leads on biostatistics strategies and business-impacting issues
Oversee CRO biostatistics functions and manage scopes of work and external statistical consultant relationships
Manage resources, set priorities, and ensure adherence to standards
Collaborate on protocol development, including 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 the Company and Biostatistics function 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 across clinical, regulatory, and commercial teams
Contribute to departmental SOPs, standardization efforts, and statistical training
Maintain current knowledge of statistics, drug development, and regulatory guidance
Participate in due diligence evaluations of external study designs and clinical trial data
Assist with business development activities at conferences and industry meetings
Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and interactions with key opinion leaders
Present at industry conferences representing AskBio
Participate in vendor evaluation, selection, and management

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

Opportunity for secondment to AskBio for a duration determined by Bayer and AskBio leadership, typically one to two years
Equal Opportunity Employer
Reasonable accommodation available for qualified individuals with a disability or disabled veteran