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Job Location: Philadelphia, PA
This position is responsible for providing strategic and tactical direction for statistical activities across all projects in all phases of development and ensuring that proper statistical analyses and interpretations are carried out. This position will be responsible for managing all CRO activities related to statistics, programming and data management to support all development programs. S/he will be responsible for building the biometrics function at Spark.
- 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, including endpoint specification, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)
- Manages all CRO statistics activities (including programming and data management) as needed
- Provides statistical input into other relevant functional groups activities and participates in interdepartmental processes
- Oversees the operations and procedures for the collection, editing, verification and management of data; works directly with CROs
- 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.
- Serves as statistical lead for all studies
- 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.)
Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employees goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
Foster Sparks Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that how they achieve performance objectives is just as important as what they accomplish.
- Excellent written communication skills, including competent grammatical/technical writing ability
- Excellent oral/interpersonal communication skills, including public speaking/presenting ability
- Strong independent work ethic
- Strong organizational skills
- Strong teamworking ability
- Advanced proficiency using SAS computing package 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
- Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
- Global travel required (approximately 15%)
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 Head of Clinical Development.
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.
Masters or PhD in statistics or related field
Generally has 10 years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred
Fluent in English (oral and written)
Experience with regulatory agencies; prior record of regulatory approvals preferred
Prior people management experience and experience identifying organizational needs (talent, process, technology) is required??
WHO WE ARE:
Transforming Patients Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
How To Apply:
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