The Director Biostatistics will oversee and guide the statistical work across Company 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. 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 Company`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 Company`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.

 Experience with global regulatory submissions.

 Prior experience overseeing statistical work of vendors.

 Comfortable with statistical software applications.

 Excellent written and oral communication skills, including presentation skills.

 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%).