Senior Director, Biostatistics, Clinical Operations

AskBio Inc.; Durham (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc., a Bayer subsidiary, seeks a Senior Director, Biostatistics to lead statistical strategy across non-clinical, CMC, and clinical programs. You will supervise statisticians, ensure rigorous study design, analysis, and reporting, and partner with cross-functional teams to advance gene therapy programs.

You will collaborate with regulatory authorities (FDA/EMA) and guide submissions while maintaining up-to-date knowledge of statistical methods and drug development guidelines.

Qualifications

• Senior/lead biostatistics role with strategic impact.
• Experience partnering with FDA/EMA and other regulators.
• Strong track record in design, analysis, and reporting of trials.

Responsibilities

• Provide technical leadership for clinical development programs.
• Oversee statistical analyses, SAPs, and clinical study reports.
• Mentor statisticians, programmers, and data managers.
• Coordinate with CROs and external statistical consultants.
• Represent Biostatistics in regulatory interactions and submissions.
• Develop standards and SOPs; ensure high-quality deliverables.

Skills

Statistical leadership

Clinical trial design

Regulatory strategy

Cross-functional leadership

Education

PhD in Biostatistics or related field

MD/PhD considered a plus

Tools

SAS

R

Python

Job description

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our Vision

Pioneering science to create transformative molecular medicines.

Our Mission

Lead innovative science and drive clinical outcomes to transform people's lives.

Our Principles

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our Values

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.

Position Summary

The Senior Director, Biostatistics, provides technical leadership and operational oversight for the development of clinical strategies and the design, implementation, and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. In addition, this role performs peer review of clinical trial designs and reports for other biostatisticians in the Biometrics group. The role collaborates closely with cross-functional teams across all phases of drug development, provides guidance and management to statisticians to ensure high-quality and timely deliverables, supports regulatory interactions, and serves as the statistical representative in defense of the company's position and approach on statistical issues and global drug approvals.

This is an US hybrid position which can be based in RTP, NC, Philadelphia, Ohio and will report to the Head, Biometrics, Clinical Operations.

Job Responsibilities

• Responsible for all deliverables related to statistical content.
• Provide guidance and management to statisticians, programmers, and data managers to ensure high-quality and timely deliverables.
• Advise and influence senior leadership and functional leads on biostatistics strategies and functional issues that have a business impact.
• Oversee the biostatistics function at CROs and manage scopes of work and relationships with external statistical consultants as needed.
• Manage resources, set priorities, and ensure consistency and adherence to standards.
• Collaborate on protocol development, including study design, endpoint selection, and power and sample size assessments.
• Take responsibility for statistical analysis plans, data analysis, and clinical study report content.
• Support Data Monitoring Committee charters and meeting preparation.
• Represent the Company and the Biostatistics function in written and in-person interactions with the FDA, EMA, and other health authorities.
• Support regulatory submissions and interactions, including IND and BLA filings, and support potential partnering requests.
• Serve as an integral member of cross-functional project teams and provide statistical input to clinical development plans, protocols, synopses, investigator brochures, regulatory submissions and responses, scientific publications, and presentations.
• Develop solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams and communicate solutions cross-functionally.
• Contribute to the creation and maintenance of departmental SOPs and standardization efforts, and provide training on statistical topics.
• Maintain current knowledge of developments in statistics, drug development, and regulatory guidance.
• Participate in due diligence evaluations of study designs and clinical trial data for external partnership opportunities as needed.
• Assist with business development activities at key conferences