The Lead Project Statistician will be responsible for strategic statistical and ‘hands on’ day to day support for several projects in support of Spark’s clinical development programs. This Project Lead will act as the lead statistician for more than one projects, contribute and collaborate on project teams, develop 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, data reporting (TFLS) for CSR/DSUR/IB reporting, regulatory activities and safety assessment. This role will be a core member of the Study and Clinical Project teams, key partner with R&D colleagues and collaborate across Biometrics and RWE functions to progress Spark’s portfolio of clinical stage gene therapies.
Education and Experience Requirements
- Lead the statistical strategy for projects and participate as a core member on clinical project teams.
- Be accountable and responsible for the statistical design, analysis plans, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 1-4 clinical trials including integrated analyses across trials.
- 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.
- Mentor and lead study level statisticians.
- 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.
- 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.
- Monitors program progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
Key Skills, Abilities, and Competencies
- PhD in Biostatistics or Statistics with ≥ 7 years of pharmaceutical or CRO industry experience (MS candidates with significant related experience may be considered).
- Experience in design and reporting of Phase 1-3 clinical trials.
- Experience supporting regulatory efforts.
- Deep and broad statistical expertise in methodologies such as Mixed Models, Bayesian approaches, Interim Analyses including Futility, 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.
Complexity and Problem Solving
- Extensive SAS and R programming required.
- Extensive experience reporting clinical studies to CDISC standards
- Expertise and experience in ADaM specifications and datasets
- Experience writing statistical analysis plans and mock TFLs for clinical study reporting.
- Experience working on clinical study teams and project teams to design studies including sample size calculations.
- Experience supporting DSURs, IBs and DMCs.
The successful candidate will need to be able to drive the analyses of complex endpoints, be experienced with complex innovative statistical designs and be solution driven in agile environment
Internal and External Contacts
Reports to the head of biostatistics, collaborates closely with the program clinical development and assets leads, regulatory lead, clinical sciences lead, translational science lead, statistical programming lead, data management lead and other key functions involved in the clinical program
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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