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Head of Biometrics and Real World Evidence

Date: Apr 7, 2021

Location: PA, US

Company: Spark Therapeutics

 

The Head of Biometrics and Real World Evidence 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.  S/he will be responsible for developing functional infrastructure and in building the biometrics capabilities at Spark and, in collaboration with the Heads of Clinical Development & Regulatory Affairs, sets or significantly influences the long-term strategic direction for Biometrics in-line with the broader Development strategy.  The Head of BRWE will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.

 

 

Responsibilities

% of Time

Job Function and Description

35%

 

  • 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
  • Serves as the point of escalation for all biometric functions for Asset & Study teams to ensure the timeliness and accuracy of biometric deliverables
  • Provides support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (e.g., advisory panels or other meetings)
  • Presents analyses to internal and external audiences (e.g. regulatory agencies, collaborators, investigators, vendors, alliance partners, etc.)

 

 

 

 

 

 

 

 

25%

 

  • 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
  • Provides 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)
  • Provides 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)

 

25%

 

  • Oversees the operations and procedures for the collection, editing, verification and management of data
  • Manages 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.
  • Collaborates with partner functions to provide statistical programming, systems analysis and database management support for observational studies/projects using internal observational health related database resources
  • Ensures that clinical outcome assessment (COA) and patient reported outcome (PRO) data are captured using the most appropriate & efficient tools and methods.

 

 

 

 

 

 

 

 

 

 

15%

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

  • Masters or PhD in statistics or related field
  • Generally has 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

Key Skills, Abilities, and Competencies 

Setting Strategy

  • Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty
  • Intellectual curiosity and dedication to science, innovation, and complex problem-solving
  • Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

  • Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process
  • Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice
  • Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

  • Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”
  • Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action
  • Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

  • Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
  • Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities
  • Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark

 

 

 

  • 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

 

Complexity and Problem Solving

      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

 

Internal and External Contacts

This role reports to the Chief Medical Officer

 

This role 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.