Head of Medical Affairs Statistics / RWE Co-Lead

The Director, Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The successful incumbent will serve the knowledge needs of patient and prescriber communities that go beyond the targeted focus of regulators.

Responsibilities and Accountabilities:

• Advising, planning and execution of exploratory analyses for secondary publications
• Input in CRO selection and participation in governance; direct and supervise programmers and CROs in the execution of exploratory analyses
• Statistical leadership and strategic partnering with key stakeholders for the design and analysis of registry trials and RWE (Real World Evidence) studies initiated by the commercial organization, including building strong relationships with quantitative counterparts in key partner organizations
• Statistical leadership and strategic partnering with key stakeholders for life-cycle-management (LCM) clinical trials initiated by the commercial organization; evaluate alternatives to traditional randomized clinical trials that make use of electronic health records, insurance claims databases, and/or registries in support of key messages
• Evaluate statistical validity of proposals for investigator sponsored trials, and advise on reasonable improvements to ensure the highest quality of published evidence.
• Develop, assess and conduct training in basic statistical methods and topics as needed
• Put in place processes and tools that ensure reproducibility of all published results providing stewardship for data integrity and archival
• Coordinate additional analyses of clinical data needed for local value propositions and market access
• Agile use of our in-house RWE facility for tactical insights and feasibility analyses

Qualifications:

Education

• A graduate degree in Statistics, Epidemiology, or related field is required; Ph.D. preferred.

Experience

• A track record of contributions to and leadership in collaborative medical/clinical research
• At least 12 years of industry experience, of which at least 7 years of experience in Medical Affairs or other market facing organizations

Competencies

• Demonstrated use of innovative / creative statistical methodology for exploratory statistical analyses of clinical data
• Profound knowledge of clinical data
• Ability to think out of the box of regulatory requirements
• Familiar with causal inference based on observational data
• Comfortable around M.D.s, both internal and external to the company
• Strong interpersonal and communication skills (verbal and written in English)
• A solutions oriented mindset
• Hands-on programming skills in SAS / R

Working Conditions

• This is a hybrid position. Three in-office days per week are required with one of these days including a Monday or Friday.

Travel Requirements

• Occasional travel to scientific conventions

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

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