Sr. Director, Biostatistics & Statistical Programming

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 unlock the power of gene therapy to accelerate healthcare transformation. 

 

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

 

 

Primary Duties

The Sr. Director, Biostatistics and Statistical Programming, is responsible for developing the strategy and overseeing 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. Additionally, this leader is responsible for providing strategic and operational leadership of the statistical programming function within Development and Product Strategy (Dev&PS), enabling delivery of complete, high quality and reliable clinical trial information to enable internal decision making, regulatory approval and market acceptance. This role reports to the Head of Biometrics.

As a people leader, the Sr. Director, Biostatistics and Statistical Programming, is expected to model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals. This leader will foster a culture of innovation, collaboration, trust, transparency, and the highest degree of stakeholder satisfaction.

As a member of the Biometrics leadership team, the Sr. Director, Biostatistics and Statistical Programming, will contribute to the vision, direction, and strategy of Biometrics.

 

Responsibilities

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. 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.

Establish and implement asset level statistical programming and analytics strategies to develop and execute statistical analysis and reporting deliverables in a timely and high-quality fashion in support of regulatory filings, publications and other high-profile business activities across all Spark clinical trials spanning Phase 1-4.

Provide leadership to the Biostatistics and Statistical Programming Teams, which includes direct and indirect reports: Coach team members on their performance, development, and career interests. 

Drive the creation/maintenance of, and provide training on statistical topics, and departmental SOPs, WPs.

Ensure comprehensive departmental SOPs are in place, along with other processes, to conform with industry and regulatory requirements, and drive adoption of innovative programming technologies to automate and accelerate the production of the Statistical Programming deliverables. 

Ensure effective quality oversight and management of our external partners (e.g., independent contractors, CROs, labs, technology providers, etc.) performing statistical programming services on behalf of Spark.  

Develop strong working relationships with key stakeholders throughout Spark, with the ability to think strategically across a broad portfolio and effectively express their views to senior management.

 

Education and Experience Requirements

MS degree in Biostatistics / Statistics with a minimum of 15 years of experience or PhD in Biostatistics / Statistics with a minimum of 12 years of pharmaceutical industry experience, including at least 10 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.

Proven success managing the oversight of external partners is required.

Expertise in visualization software/tools such as Spotfire, Tableau, SAS, Python, R, etc. is required.

 

Key Skills, Abilities, and Competencies

Global clinical trial expertise and a successful track record of leading through influence, working across global organizational matrices. 

Exceptional interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution.

Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.

Demonstrated expertise in the management of clinical trial data.

Prior experience providing programming support in gene therapy, rare disease and/or observational studies is preferred.

Strong knowledge of industry leading programming tools, including SAS, R, and Spotfire; well versed in industry trends and emerging technologies supporting data analysis.

 

Complexity and Problem Solving

Demonstrated ability to problem solve by producing fit-for-purpose data integration solutions and data collection techniques that support clinical/medical decisions and project milestone decisions.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse technical expertise to be a credible interface to all global development and business partners (medical, development, translational, quality, regulatory, etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage and influence a geographically diverse team.

 

Internal and External Contacts

The Sr. Director, Biostatistics and Statistical Programming, is accountable to the Chief Medical Officer and Head of Biometrics for ensuring the statistical strategy and the integrity and quality of data deliverables to meet program-level objectives, regulatory requirements, pharmacovigilance data review and medical affairs.

Collaborate with various Spark colleagues in the collection of laboratory and clinical study data with a focus on efficiency.

Interact with internal and external partners (i.e., CROs, SMOs, technical vendors, local site networks) to ensure accuracy and quality are applied to data collection and analysis with a wide variety of data types.

 

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $241,000  to $361,400 

 

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.