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Lead Statistician (Associate Director Level)

Spark Therapeutics
Working from home. Hybrid and remote options available for select opportunities.
Salary not provided
Closing date
May 11, 2023

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Physical Sciences, Statistics
Job Type
Organization Type

Job Details

Primary Duties

The Lead Statistician reports into the Head of Biostatistics and will be responsible for strategic statistical and ‘hands on’ day to day support for several studies in support of Spark’s clinical programs. This Lead will act as a lead statistician for Spark’s Hemophilia A studies, contribute to the statistical design/strategy and statistical analysis plans, conduct exploratory analyses using R/SAS and support responses to regulatory questions. This role will contribute to Protocols, CSR/DSUR/IB reporting, regulatory activities and safety assessment. This role will be a member of the clinical teams, key partner with R&D colleagues and collaborate across Clinical Development functions to progress Spark’s portfolio of clinical stage gene therapies.


  • Contribute to the statistical strategy for Hemophilia A and participate as a member on study/development subteams.
  • Initiate, drive and implement novel methods and innovative trial designs.
  • Provide statistical input into protocol and case report form (CRF) development (e.g., trial design, sample size estimation, statistical methods for protocols, edit checks for clinical trial data)
  • Participate in regulatory (e.g., pre-IND, NDA) activities including authoring of statistical sections and participating in regulatory meetings/written responses.
  • Contribute to planning and execution of exploratory analyses, data visualization and statistical consultation on cross-functional teams.
  • Collaborate cross-functionally (e.g. data management, programming, safety, clinical, etc) to ensure timeliness and quality for statistical deliverables.
  • Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings.
  • Write and review statistical analysis plans and TFLs.
  • Interpret and clearly communicate statistical results and concepts to non-statisticians.
  • Provide statistical support and outputs for conference presentations, manuscripts, CSRs, DMCs, etc.
  • Develop/Write statistical standard operating procedures (SOPs) and input into general standardization efforts (e.g., CDISC, TFLs, eCRFs).
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Education and Experience Requirements

  • PhD in Biostatistics or Statistics with ≥ 6 years of pharmaceutical or CRO industry experience (MS candidates with significant related experience may be considered)
  • Experience in designing, conducting and reporting Phase 3 clinical trials data in CSRs to CDISC standards.
  • Experience supporting regulatory efforts.
  • Deep and broad statistical expertise in methodologies such as Mixed Models, Complex Innovative designs, Modelling and Simulation methods, and in SAS, R.
  • Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
  • Excellent verbal and written communications skills, strong presentation skills, able to translate statistical concepts to non-statisticians.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Ability to organize multiple work assignments and establish priorities.
  • Experience with rare diseases and/or gene therapy development preferred

Key Skills, Abilities, and Competencies

In-depth skills in designing and reporting advanced stage clinical studies to CDISC standards

Competencies in ADaM specifications and datasets

Abilities writing statistical analysis plans and mock TFLs for clinical study reporting and ISS/ISE.

Competencies in working on clinical study teams and project teams to design studies including sample size calculations.

Experience supporting DSURs, IBs and DMCs.

Extensive SAS and R programming.

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.

Nearest Major Market: Eugene

Join the Spark Team

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.

We don't follow footsteps. We create the path.

Learn more about Spark Therapeutics and view other openings.


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