This leader is responsible for creating and implementing the strategic direction for biostatistics, real world evidence, programming, data management and eData collection activities across all projects, in all phases of development and ensuring that proper statistical analyses and interpretations are carried out. The Head of Biometrics and Real-World Evidence (RWE) will be responsible for developing functional infrastructure and building the biometrics capabilities at Spark in collaboration with the Heads of Clinical Development & Regulatory Affairs and will set or significantly influence the long-term strategic direction for Biometrics in-line with the broader Development strategy. The Head of Biometrics and RWE will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.
Develop, implement and drive evolution of Spark’s statistics, data management, programming, RWE and eCOA capabilities.
Serve as a strategic partner working closely with clinical development and other relevant functional groups in providing statistical input to clinical development plans and trial designs.
Serve as the point of escalation for all biometric functions for Asset & Study teams to ensure the timeliness and accuracy of biometric deliverables.
Provide support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (e.g.
, advisory panels or other meetings)
Present analyses to internal and external audiences (e.g.
regulatory agencies, collaborators, investigators, vendors, alliance partners, etc.)
Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures, either directly or through management of CROs
Provide expert statistical review/Q.C. and input into statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.e. database design, critical data checks and validation)
Provide input on relevant sections of research protocols and regulatory documents including endpoint specification, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)
Oversee the operations and procedures for the collection, editing, verification and management of data.
Manage data release and review for clinical projects; reviews and participates in QC and finalization of various documents, including abstracts, posters, manuscripts, publications, press releases, study reports, regulatory documents, etc.
Collaborate with partner functions to provide statistical programming, systems analysis and database management support for observational studies/projects using internal observational health related database resources.
Ensure that clinical outcome assessment (COA) and patient reported outcome (PRO) data are captured using the most appropriate & efficient tools and method.
Provides leadership to team members including managing performance, developing people, hiring and integrating new team members and fostering Spark’s culture, mission, vision and values.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- Masters or PhD in statistics or related field
- 15+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred.
- 5+ years of experience leading a statistical or biometrics function.
- Demonstrated experience in early clinical development.
- Experience in rare disease preferred.
- Experience with regulatory agencies; prior record of regulatory approvals preferred.
- Prior people management experience and experience identifying organizational needs (talent, process, technology) is required.
Internal and External Contacts
- Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
- Excellent written communication skills, including competent grammatical/technical writing ability.
- Excellent oral/interpersonal communication skills, including public speaking/presenting ability.
- Strong independent work ethic and a willingness to be engaged with the project teams.
- Strong organizational skills
- Strong teamworking ability
- Advanced proficiency using statistical computing platforms in the pharmaceutical area.
- Familiarity and ability to learn alternative relevant statistical computing software.
- Strong analytical, detail-oriented mindset, ability to solve moderate to complex problems.
- Practical experience applying statistical concepts and methodologies to clinical trial design/analysis and within regulatory guidelines.
- Strong working knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (i.e. CDISC/ADaM)
- Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.
- Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects.
- Ability to plan and think strategically and critically.
- Ability to define organizational needs such as talent capabilities, processes and technology and to function as mentor and to develop junior staff.
- Ability to critically evaluate and analyze scientific data and literature.
This role reports to the Chief Medical and Product Strategy Officer and will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.
Other Job Requirements
Global travel required (approximately 15%)
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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