Head of Medical Affairs Statistics​/RWE Co-Lead

Head of Medical Affairs Statistics / RWE Co-Lead

Join to apply for the Head of Medical Affairs Statistics / RWE Co-Lead role at Bio Space

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.

• 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

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

• 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

• 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

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

• Occasional travel to scientific conventions

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit

• Director

• Full-time

• Other
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