Associate Director, Statistical Programming

The Associate Director statistical programming leads the programming activities for multiple clinical development programs by providing strategic and hands-on input in a cross-functional setting using both internal and external resources. The Associate Director will oversee and participate in programming activities in support of the timely and accurate execution of statistical analysis plans supporting clinical study reports, publications, ad hoc analyses and regulatory submissions. The Associate Director will work with the department leadership to build systems and processes to support transparent, reproducible, and accurate delivery of clinical study results.

This is a ground floor opportunity to help to build the statistical programming function within the Biometrics department.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco). The position reports to the Head of Biometrics and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.

Responsibilities

• Responsible for leading the programming activities on multiple projects/studies.

• Responsible for providing programming expertise to review/QC the programming outputs provided by external CRO resources and programming consultants, including timelines and budgets, datasets, QC outputs, programming related documents, and debugging programming errors.

• Responsible for establishing and maintaining a transparent data flow process from raw data to final outputs.

• Accountable for all statistical programming deliverables, including SDTM and ADaM datasets and specifications, and tables, figures and listings (TFLs), providing quality control for datasets including resolving Pinnacle 21 errors discrepancies, maintaining records and timelines, and identifying and communicating changes in project requirements that may affect key deliverables.

• Accountable for the execution of statistical analysis plans that support clinical development plans and clinical protocols, to ensure transparency, adequacy and accuracy.

• Responsible for providing technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).

• Responsible for contributing to developing programming standards, including SOP development.

• Collaborate with Biostatistics, Data Management, Clinical Operations, Clinical Development, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Bachelor or Masters degree in a scientific or computer sciences discipline.

• Minimum of 10+ years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry; 8+ years with a Masters degree; 6+ years with a PhD.

• Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus

• Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies and Pinnacle 21 validator.

• Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistical programming.

• Experience in building programming packages for NDA/MAA submissions is preferred.

• Experience managing external programming resources is preferred.

• Knowledge of clinical data management systems.

• Able to collaborate effectively with internal, cross-functional and external study teams to meet project timelines.

• Self-directed, technically strong, and a leader maintaining a strategic prospective with regard to statistical programming processes and the management of statistical programming projects.

• Excellent organizational skills and attention to detail.

• Able to set priorities and juggle multiple projects and demands.

• Able to work independently while exercising initiative, flexibility and sound judgment.

• Ability to operate in alignment with Pliant's values.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $200,000 - $210,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.

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