Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.

The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b trial of bexotegrast for the treatment of IPF and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC. 

Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.

 

Description

 

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.

 

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/. 

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Pliant Therapeutics, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Our system has flagged this application as potentially being associated with bot traffic. Please turn off any VPNs, clear your browser cache and cookies, or try submitting your application in a different browser. If this issue persists, please reach out to our support team via our help center.
Please complete the reCAPTCHA above.