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Senior Statistical Programming Manager

2 months ago

Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time
Job Overview

The Senior Statistical Programming Manager will play a pivotal role as an individual contributor, overseeing various programming initiatives for Madrigal Pharmaceuticals. This position encompasses all stages of clinical development and involves collaboration with biostatisticians and programming teams, both internally and at contract research organizations (CROs), to achieve research and development goals.


Key Responsibilities:

  • Translate statistical objectives into actionable programming specifications that can be utilized by internal teams or external CRO partners to create validated programming in alignment with R&D goals.
  • Prepare and review CDISC (SDTM and ADaM) data specifications to ensure compliance with regulatory standards for clinical trial databases.
  • Develop and supervise the creation of tables and graphical representations of data to facilitate the effective interpretation of clinical trial results.
  • Create advanced programs using R or SAS to enable timely analysis of critical data.
  • Work closely with study teams and management to ensure a smooth transition of programming deliverables into clinical study reports (CSRs) and other regulatory documentation.
  • Ensure comprehensive programming documentation and quality control of outputs are completed and properly archived.
  • Conduct thorough reviews of aggregated clinical, quality, and performance data, proactively addressing any quality or performance concerns in collaboration with study teams.
  • Contribute to the enhancement of processes and the development of efficient procedures for Clinical Data Review and other initiatives focused on data quality.
  • May oversee junior data analysts and programmers as necessary.

Qualifications and Skills:

  • Bachelor's degree in mathematics, computer science, data science, statistics, or a related life science field (Master's degree preferred).
  • A minimum of 5 years of experience in the pharmaceutical or biotech industry, with prior experience in regulatory submissions (7 years for a Director role).
  • Proficient in SAS and R programming languages.
  • Familiarity with regulatory guidelines (e.g., ICH, GCP).
  • Experience with CDISC data standards, medical terminology, and quality control practices.
  • Strong understanding of data cleaning procedures and best practices.
  • Prior experience managing programming delivered by CRO partners.
  • Expertise in validation techniques and documentation requirements.

Compensation:

The base salary is determined by various factors, including the candidate's qualifications, skills, education, experience, business needs, and market conditions. The role may also offer eligibility for bonuses, equity, and a comprehensive benefits package, which includes flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment decisions are based on qualifications, merit, and business needs. Applicants will be considered for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.

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