Head of Biostatistical Analysis

2 weeks ago

Boston, Massachusetts, United States Rhythm Pharmaceuticals Full time
Position Overview

Company Background
Rhythm Pharmaceuticals is a pioneering biopharmaceutical organization dedicated to enhancing the lives of individuals affected by rare neuroendocrine disorders. Our mission is to develop innovative therapies for conditions that have been historically neglected or inadequately addressed, while also providing substantial support to healthcare professionals and the families of patients. We are inspired by the resilience of patients and their advocates, which drives us to challenge the status quo, ask insightful questions, and pursue meaningful solutions. Our commitment to excellence is reflected in our adaptability, eagerness to learn, and our determination to surmount challenges collectively.


Role Summary
We are in search of a Director of Biostatistics to oversee our Biostatistics and Data Management division. Reporting directly to the Vice President, Head of Biostatistics & Data Management, this role involves leading and offering strategic insights from a biostatistical standpoint while supporting all statistical components for designated clinical initiatives within a collaborative project team framework. The ideal candidate will serve as an independent statistical authority on various projects. If you possess a strategic mindset coupled with hands-on biostatistical expertise and a dedication to maintaining high standards of data integrity and quality, this position is tailored for you.


Key Responsibilities

  • Deliver strategic guidance and direction on clinical development strategies, innovative statistical designs, sample size determinations, and oversee statistical elements in protocol formulation, statistical analysis plans (SAPs), and TLFs, along with data interpretation and analysis.
  • Collaborate with clinical project teams to design, implement, and evaluate clinical protocols and statistical analysis plans.
  • Draft statistical sections of protocols, clinical study reports, integrated summaries of safety and efficacy (ISS/ISE), and other necessary documentation.
  • Effectively manage external vendors conducting statistical analyses for Rhythm, ensuring the validation and quality control of statistical outputs.
  • Work closely with statistical programmers during dry-runs, quality checks of critical efficacy and safety data, and identification of data discrepancies.
  • Assist in the preparation of interim analysis plans, DSMB meetings, and ad hoc analyses.
  • Contribute to the statistical components of regulatory submission packages.
  • Support the clinical aspects of INDs/NDAs/BLAs/MAAs to ensure accurate representation of statistical analyses and findings.
  • Assist in the development and revision of statistical standard operating procedures (SOPs).

Qualifications

  • Master's or PhD degree in statistics or biostatistics is strongly preferred.
  • A minimum of 10 years of biostatistical experience within the pharmaceutical or biotechnology sector.
  • Ability to contribute to comprehensive clinical, regulatory, and safety discussions beyond the realm of biostatistics.
  • Excellent communication skills, both verbal and written, with the ability to convey complex concepts to diverse audiences.
  • Strong foundation in statistical principles and methodologies applicable to clinical trials.
  • Proficient in statistical programming with SAS and R, with experience in sample size calculation software.
  • Familiarity with CDISC standards for SDTM and ADaM.
  • Capability to manage multiple projects concurrently.

This position operates under a hybrid work model. Rhythm Pharmaceuticals is an equal opportunity employer and values diversity in the workplace.

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