Full-Time

Senior Manager

Statistical Programming

Posted on 8/14/2024

Pliant Therapeutics

Pliant Therapeutics

51-200 employees

Develops treatments for fibrotic diseases

Biotechnology
Healthcare

Compensation Overview

$175k - $190kAnnually

+ Equity + Annual Target Bonus

Senior, Expert

San Bruno, CA, USA

Hybrid position requiring 3 days/week at Pliant in South San Francisco.

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, proteins that help cells stick together and communicate. This focus allows Pliant to create specific and effective therapies for various fibrotic conditions. Unlike many competitors, Pliant emphasizes a deep understanding of fibrosis and integrin biology, which informs their drug development process. The company's goal is to stop the progression of fibrotic diseases and restore normal organ function, ultimately improving the lives of patients affected by these conditions.

Company Stage

IPO

Total Funding

$201.4M

Headquarters

San Francisco, California

Founded

2015

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

8%
Simplify Jobs

Simplify's Take

What believers are saying

  • Positive Phase 2a trial data for bexotegrast in PSC boosts Pliant's clinical credibility.
  • Orphan Drug Designation for PLN-74809 in IPF and PSC offers regulatory advantages.
  • Advancements in precision medicine enhance efficacy of Pliant's targeted drug candidates.

What critics are saying

  • Intensifying competition in IPF treatments may impact Pliant's market share.
  • FDA scrutiny on fibrosis drugs could delay Pliant's approval timelines.
  • Geopolitical tensions may disrupt global clinical trial operations for Pliant.

What makes Pliant Therapeutics unique

  • Pliant focuses on integrin-targeting therapies for fibrotic diseases, a unique approach.
  • PLN-74809 is a dual selective inhibitor for IPF and PSC, showing innovation.
  • Partnership with Novartis for PLN-1474 highlights strategic collaboration in liver fibrosis.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Company Match

Remote Work Options

Flexible Work Hours

Professional Development Budget

Wellness Program

Mental Health Support

Gym Membership

Phone/Internet Stipend

Home Office Stipend

Paid Vacation

Paid Sick Leave

Paid Holidays

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Employee Stock Purchase Plan

Performance Bonus

Relocation Assistance

Employee Referral Bonus

Student Loan Assistance

Adoption Assistance

Childcare Support

Elder Care Support

Pet Insurance

Bereavement Leave

Commuter Benefits

Meal Benefits

Legal Services

Employee Discounts

Company Social Events

INACTIVE