Senior Director, 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 Parkinsons disease and Pompe disease. AskBios 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 peoples 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 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 whats 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 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 companys position and approach on statistical issues and global drug approvals.

This is an US hybrid position which can be based in RTP NCPhiladelphia 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. 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.

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 jobrelated 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 or sending us an email at .

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.