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Full-Time

Senior Manager

Statistical Programming

Confirmed live in the last 24 hours

Pliant Therapeutics

Pliant Therapeutics

51-200 employees

Develops treatments for fibrotic diseases

Hardware
Biotechnology

Compensation Overview

$175k - $190kAnnually

+ Equity + Annual Target Bonus

Senior, Expert

San Bruno, CA, USA

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
Required Skills
R
Data Analysis
Requirements
  • Bachelor or Masters degree in a scientific or computer sciences discipline.
  • Minimum of 8+ years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry; 6 years with a Masters degree.
  • Advanced SAS programming skills
  • Experience in other statistical software, such as R is a 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.
Responsibilities
  • Responsible for leading the programming activities on multiple projects/studies.
  • Responsible for reviewing and providing technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).
  • Responsible for providing programming expertise to review/QC the programming work provided by external CRO, including timeline along with QC outputs, datasets, and programming related documents, and debugging programming errors.
  • Accountable for all statistical programming, including programming SDTM, ADaM datasets, tables, figures and listings (TFLs), authoring dataset specifications, providing quality control for datasets, TFLs, maintaining records and timelines, 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 contributing to the development of departmental macros, work instructions, and departmental initiatives, such as creating ADaM dataset standards and TLF mock shells.
  • 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.

Pliant Therapeutics develops treatments for fibrotic diseases, which cause thickening and scarring of connective tissue, leading to organ dysfunction. Their products work by targeting the biological mechanisms behind fibrosis, particularly through the inhibition of integrins, which are proteins that help cells stick together and communicate. This targeted approach allows Pliant to create effective treatments for various fibrotic conditions. Unlike many competitors, Pliant focuses specifically on the science of fibrosis and integrin biology, aiming to reverse the effects of these diseases rather than just manage symptoms. The company's goal is to halt the progression of fibrotic diseases and restore normal organ function, ultimately improving the quality of life for patients.

Company Stage

IPO

Total Funding

$694.9M

Headquarters

San Francisco, California

Founded

2015

Growth & Insights
Headcount

6 month growth

12%

1 year growth

17%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Pliant's accelerated development of bexotegrast for IPF and positive Phase 2a trial results indicate strong potential for successful market entry.
  • The company's participation in high-profile investor events and scientific congresses enhances its visibility and credibility in the biotech community.
  • Recent strategic appointments, including a new Chief Development Officer and Chief Regulatory Officer, bolster Pliant's leadership team and operational capabilities.

What critics are saying

  • The high costs and long timelines associated with drug development pose financial risks, especially if clinical trials do not meet endpoints.
  • The competitive landscape in biopharmaceuticals, particularly in fibrosis treatment, requires Pliant to continuously innovate to maintain its edge.

What makes Pliant Therapeutics unique

  • Pliant Therapeutics focuses specifically on fibrotic diseases, leveraging deep expertise in fibrosis and integrin biology, unlike competitors with broader therapeutic areas.
  • Their targeted approach to integrin inhibition offers a unique mechanism of action that sets them apart from other fibrosis treatments.
  • Pliant's commitment to rigorous clinical trials and data-driven development ensures high standards of efficacy and safety, distinguishing them in the biopharmaceutical market.