Statistical Leader

Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Posted
November 24 2021
Ref
816987300
Organization Type
Biotech

Primary Duties

The Statistical Leader is accountable to drive statistical solutions through a consultative approach in support of Spark’s clinical programs. This Leader will develop the strategy and oversees the statistical support for the development of multiple therapies in close collaboration with Clinical Development, Regulatory Affairs, Global Drug Safety, Clinical Operations, and Medical Affairs colleagues. This hands-on role will contribute to Clinical Development Plans, Protocols, Safety Assessment, Regulatory Reporting and Submissions including preparations and defenses as well as provide guidance and management to a team of statisticians to ensure high quality and timely deliverables. The Statistical Leader, Biostatistics will serve as the statistical representative in support of the company position/approach on statistical issues for the development of therapies globally. This role will report into the Head of Biometrics and RWE.

Responsibilities

Job Function and Description

  • Shape, lead, manage and grow the Statistics function in support of all clinical programs
  • Lead the statistical strategy and approach across the organization for all disease indications
  • Advise and influence project teams on Biostatistics strategies as well as functional issues that have a business impact
  • Act as the project statistician for at least one disease program
  • Assess, provide direction, and resolve complex stakeholder concerns both on technical and strategic topics, directly and through the team
  • Act as the subject matter expert on research and program statistical methodologies such as Mixed Models, Bayesian approaches, Interim Analyses including Futility, Modelling and Simulation methods
  • Be accountable and responsible for the statistical design, analysis, reporting and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
  • Draft the strategy and lead the writing of statistical methods for protocols
  • Set up Quality Control processes and data sets to ensure deliverables
  • Represent department in meetings with regulatory agencies.
  • Manage and review CRO deliverables.
  • Contribute to the creation/maintenance of, and provide training on statistical topics, and departmental SOPs, WPs.
  • Manage resources, set priorities, project manage statistical deliverables, activities and ensure consistency and adherence to standards therein.
  • Experience building, communicating, and driving the statistical strategy across a range of data sources and file types.
  • Partner with the wider Biometrics and RWE team (e.g. Data Management, SAS Programming, etc.) to ensure high quality clinical trials databases and analysis data sets
Manage Statistics team to achieve business goals and objectives.

  • Foster Spark’s Culture.Role model the Spark Values. Create an environment where team members thrive 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.
  • Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • 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, holding 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 continuously communicating priorities, decisions and changes; adjusting goals as needed.
  • Develop people. Understand each individual team member’s career 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 and stretch opportunities.

Education and Experience Requirements

  • MS degree in Biostatistics / Statistics with a minimum of 10 years of experience or PhD in Biostatistics / Statistics with a minimum of 8 years of pharmaceutical industry experience, including at least 2 years of experience managing people
  • 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 and CDISC.
  • Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical function.
  • Proven track record of partnering with and supporting development programs in the pharmaceutical industry
  • Experience with regulatory submissions in the US and EU
  • Experience with rare diseases and/or gene therapy development preferred

Key Skills, Abilities, and Competencies

  • Demonstrated ability to work in a team environment with clinical team members with good interpersonal, communication, writing and organizational skills.
  • Demonstrated success in managing and developing teams with a focus on Workforce Planning and Talent Management strategies.

*This position is equivalent to Director level

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.


Nearest Major Market: Philadelphia



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.

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