Senior Director, Biostatistics - Biostatistics, Clinical Operations

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
• Develop and lead the statistical strategy for assigned clinical development programs, ensuring that individual study designs, endpoints, analysis methods, and evidence-generation plans collectively support key development decisions, regulatory objectives, and the target product profile
• Provide leadership on estimated development, handling of intercurrent events and missing data, multiplicity control, sensitivity analyses, and other statistical strategies needed to support interpretable and regulatory defensible conclusions
• 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
• Lead statistical planning and execution for regulatory submissions, including integrated summaries of safety and effectiveness, submission-ready analyses and datasets, responses to health-authority questions, and preparation for regulatory inspections and advisory committee meetings, as applicable
• Establish and maintain risk-based quality-control, validation, documentation, and governance processes for statistical deliverables, ensuring that analyses are reproducible, auditable, inspection-ready, and compliant with applicable GCP and regulatory requirements
• 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 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

Minimum Requirements

• Ph.D. in Statistics or a related field with 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

Preferred Skills & Abilities

• Experience with adaptive and Bayesian study design simulation techniques
• Experience in rare diseases and/or gene therapy

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].

Agencies:  Please do not contact any employee at AskBio about this requisition.  Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.  All agencies must have a prior executed service agreement with AskBio prior to any search engagement.  If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.