Senior Manager, Biostatistics
Pliant Therapeutics
Pliant Therapeutics is a public, clinical 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 disease. The Company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
The Company’s lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and are currently in Phase 2a clinical trials for these indications. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
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 initiating 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.
The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
Description
The Senior Manager, Biostatistics, supports the biostatistical and programming activities for one or more clinical development programs by providing strategic input in a cross-functional setting from conceptualization of clinical program plans to results interpretation and dissemination. The Senior Manager supports activities related to timely and accurate delivery of clinical study designs, sample size estimation, statistical analysis plans, clinical study reports and regulatory submissions, provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, and regulatory submissions.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco). The position reports to the Senior Director, Biostatistics.
Responsibilities
- Provides statistical input to clinical development plans, clinical study concepts and protocols, case report forms, clinical study reports, regulatory documents, scientific publications, internal and external meetings and presentations.
- Authors and executes statistical analysis plans that support clinical development plans and clinical protocols, to ensure statistical integrity, adequacy, and accuracy.
- Responsible for production of biostatistics deliverables (planned, post-hoc, and/or exploratory analyses) by providing oversight of the work performed by CROs, managing external Biostatistics and Statistical Programming consultants, or performing the work themselves, to ensure timeliness and quality of analysis data and statistical outputs.
- Supports development, interpretation, and presentation of topline study results in close collaboration with the clinical and cross-functional teams.
- Ensures all biostatistics activities comply with industry norms, health authority regulations, ICH/GCP guidelines and company SOPs.
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.
- PhD or MS in (bio)statistics or mathematics.
- At least 3 years of pharma/biotech sponsor-side experience with MS degree or 1 year experience with PhD. Rare disease or Oncology experience is a plus.
- Comprehensive knowledge of clinical trials methodology, and statistical software packages. Proficiency in SAS required, and knowledge of other languages (R) is a plus.
- Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistics and drug development.
- Experience within early and late-stage development phases, including selection of relevant clinical study endpoints and outcome measures.
- Proven track record publishing peer-reviewed study results and/or innovative statistical designs and methods.
- Excellent interpretation and presentation skills and ability to communicate statistical concepts and data to non-statisticians.
- Knowledge of CDISC requirements for SDTM and ADaM.
- Knowledge of clinical data management systems.
- Able to collaborate effectively with internal, cross-functional and external study teams to meet project timelines.
- 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.
Position location
- South San Francisco, California
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 $180,000 - $192,000. 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/.