Director Biostatistics

Summary of Position

The Director Biostatistics will oversee and guide the statistical work across Curium early and late phase clinical development, HEOR/RWE and medical affairs studies which includes biostatistics and clinical programming work performed by external vendors.

The successful candidate will need to have proven experience in statistical planning and data analysis in oncology diagnostic and therapeutic development, ideally in nuclear medicine and radio-ligand field. The candidate will have a comprehensive understanding of and hands-on experience with trial design, EDC data design and capture, Statistical Analysis Plans (SAP), providing guidance on Table, Listing and Figures, conducting data analysis and data exploration as well as a working knowledge of clinical programming and data management. This individual will oversee the statistical and programming work outsourced to external vendors. This position will report to the Chief Medical Officer (CMO).

Essential Functions

• Provide statistical expertise to support clinical development objectives and strategy and quantify the benefit, risk, value and uncertainty of the target product profile.
• Statistical support to clinical trials including trial design, definition of endpoints, and Go/No Go criteria, cross-functionally and providing high quality decision support.
• Evaluate and recommend statistical methodology, analyze data, and contribute to the strategic planning and execution of the clinical development plan. Contribute to clinical study designs and protocol development.
• Setting the standards (and carrying out compliance) for statistical work within the clinical development.
• Hold external partners and vendors accountable to the high-quality standards of deliverables.
• Interact with Health Authorities and Reimbursement/Payer Organizations for specific projects/indications.
• Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
• Defines strategies or leads Curium`s response to sophisticated technical issues for specific medical/statistical aspects.
• Maintains a high degree of understanding and awareness on new statistical methodologies.
• Develops and maintains relationships with international key opinion leaders, consultants and collaborative groups.
• Accountable for the statistical work on the Curium`s products worldwide
• Functionally contribute to any due diligence/in licensing deals
• Review and oversee vendor activities and documents including SAPs, case report forms, edit specifications, clinical programming outputs, randomization plans, etc.
• Oversee planning and conduct of data analysis of safety, efficacy, pharmacokinetics and pharmacodynamic data.
• Reviews and interprets interim and final clinical study analysis, integrated summaries, etc.
• Contribute to reports and responses on statistical topics for health authorities, development partners, and publications.
   

Requirements

• PhD or MS in Biostatistics or related discipline. 
• 15 or more years of relevant experience in pharmaceuticals or life sciences industry required.
• Thorough understanding of statistical principles and clinical trial methodology. Proven knowledge and expertise in statistics and its application to clinical trials.
• Experience in programming and data management is preferred.
• Experience with early and late-stage oncology clinical trials in nuclear medicine and radioligand field is a plus.
• Experience with global regulatory submissions
• Prior experience overseeing statistical work of vendors.
• Comfortable with statistical software applications
• Excellent written and oral communication skills in English, including the ability to effectively create and deliver presentations, are required due to interaction with our diverse team
• Strategic leadership and communication skills, strong initiative, ethics, and judgment, and demonstrated ability to positively represent the company
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Ability to collaborate with scientific/technical personnel, commercial and medical affairs
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Able to travel internationally (25%). 

Working Conditions:

• Willingness to work in a team based environment.
• Close attention to detail required.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.