Skip to main content

This job has expired

Statistical Programming Lead (Associate Director)

Employer
Spark Therapeutics
Location
Working from home. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Oct 12, 2022

View more

Discipline
Life Sciences, Biotechnology
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma

Job Details

Primary Duties:

Statistical Programming Lead provides functional expertise and leadership to clinical project teams to lead statistical programming and support the development, regulatory approval, and market acceptance of Spark Therapeutics Products. This position is primarily responsible for the design, development, and implementation of technical solutions for integrating, analyzing and reporting clinical data. This individual will use knowledge of CDISC SDTM and ADaM standards to support Biometrics in statistical analysis, including generating analysis data listing, tables, figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use their strong people management and supervisory skills to provide direct line management to the statistical programmers.

Responsibilities

Job Function and Description

  • Provides comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices
  • Develop operational processes and standards for the statistical programming group including templates for SDTM, ADaM and TLFs specifications
  • Develop and validate technical programming specifications for analysis datasets, statistical tables, figures and listings
  • Evaluate CDISC electronic data packages for completeness and ensure submission readiness of study data packages per CDISC standards and FDA guidance
  • Implement state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements
  • Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage; review annotated case report forms
  • Effectively and persuasively presents statistical programming concepts, assessment of risks and their impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
  • Manages critical deadlines, demonstrates ability to resolve issues, and ensures studies will be completed within designated timeframe
  • Contributes to the Biometrics process establishment and SOPs development
  • Coordinate the development of SAS macros and tools for repeated program use for exploratory and post-hoc analyses
  • Recognize inconsistencies and initiate resolution of data problems
  • Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with high quality
  • Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals
Education and Experience Requirements

  • BS/MS in computer science, statistics or life sciences required
  • At least 12 years programming experience in the drug development industry including support of significant regulatory filings and minimum 5 years of experience in managing technical professionals in a regulated environment
  • Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
  • Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros
  • Broad expertise in statistical programming and in developing computing strategies
  • In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21)
Key Skills, Abilities, and Competencies

Required skills for this position:

  • Previous experience supporting SAS macro and/or system utility development preferred
  • Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred
  • Advanced working knowledge of CDISC SDTM and ADaM, and extensive experience of their implementation in clinical trials analysis preferred
  • Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred
  • Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred
  • Demonstrated ability to work in a team environment with clinical team members

Complexity and Problem Solving

  • Strong problem-solving skills with ability to process complex information, break it into logical steps/tasks to help solve, present it clearly to a range of audiences
  • Demonstrated ability and desire to navigate complex situations with various levels of uncertainty
  • Ability to see and understand a broader, enterprise level perspective and understand and assess impact to statistical programming

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical operations, regulatory, medical, safety, R&D, IT, Data Analytics, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

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.

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: 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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert