Senior Director, Lead Statistical Programmer
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
Sr. Director, Lead Statistical Programmer
The Lead Statistical programmer is an individual contributor that will lead multiple programming activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the company or at a CRO to ensure meeting R&D objectives. This position may manager other internal programmers, if appropriate.
The incumbent will translate statistical objectives into relevant work products, establish programming strategies and ensure quality execution. The position will be a combination of conducting complex programming, developing programming plans and contributing to regulatory documents. In addition to hands-on work, the incumbent will coordinate with other biostatisticians/programmers on execution of other statistical deliverables
Position Responsibilities:
- Develop programming specifications based on translating Statistical Analysis Plans that can be used by either internal or external CRO partners to prepare validated programming in support of R&D objectives
- Prepare and/or review CDISC (SDTM and AdAM) data specifications to ensure regulatory acceptability of Madrigal’s clinical trial data bases
- Develop and/or oversee development of tabular and graphical representations data that enable effective interpretation of clinical trial data.
- Develop complex programs in either R or SAS that enable timely assessment of critical data analyses
- Collaborate with study teams and functional management in defining. Enables the successful transition from programming deliverables into CSRs and other regulatory documents
- Ensures programming documentation and QC of programmed outputs are completed and filed appropriately
- Perform holistic review of aggregated clinical, quality and performance data and proactively address quality or performance issues jointly with the study teams in line with issue management and risk-based quality management processes.
- Contribute to process improvement and development of efficient procedures for Clinical Data Review and other cross-functional data quality-related initiatives.
- Manages less senior data analysts/programmers
- Bachelor's degree in mathematics, computer science, data science, statistics or related life science field (Master’s degree preferred).
- At least 10 years of experience in the pharmaceutical/biotech industry with prior regulatory submission experience.
- Experienced in SAS and R programming.
- Experienced in managing a team of data analysists/programmers.
- Understanding of regulatory guidance ( e.g. ICH, GCP).
- Experience in CDISC data standards, medical terminology and quality control practices.
- Excellent understanding of and experience in all aspects of data cleaning procedures.
- Prior experience with overseeing programming delivered by a CRO partner.
- Expert in techniques and processes used to validate programming and documentation requirements.
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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