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Associate Director, Biostatistics

3 months ago

Boston, United States Rhythm Pharmaceuticals Full time
Job DescriptionJob DescriptionCompany Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
Rhythm is seeking an Associate Director, Biostatistics to join our Biostatistics and Data Management team. Reporting to Vice President, Head of Biostatistics & Data Management, you will lead and provide strategic input from a biostatistics perspective and support all the statistical aspects for assigned clinical programs in a cross-functional and highly collaborative project team environment. You will be expected to be an independent statistical lead on projects.  If you are a strategic thinker as well as a hands-on biostatistician who is committed to high standards of data integrity and quality, you will thrive in this role.

Responsibilities and Duties
  • Provide strategic input and support on the clinical development plans, innovative statistical design, sample size and power calculation, and be responsible for statistical elements in protocol development, statistical analysis plans (SAPs) and TLFs, data analysis and statistical result interpretation.
  • Work with project clinicians to design, develop, conduct, and analyze clinical protocols and statistical analysis plans.
  • Prepare statistical related sections of protocol, clinical study reports, integrated summaries of safety/efficacy (ISS/ISE), etc. as needed.
  • Proactively manage the vendors that conduct statistical work for Rhythm, validate and QC the statistical deliverables from vendors. Ensure accuracy, consistency, and quality output.
  • Work closely with statistical programmers in dry-runs, QC of key efficacy and safety data, identifying data issues, etc.
  • Support interim analysis plan, DSMB meetings, ad hoc analysis, etc.
  • Help prepare the statistical components in regulatory submission packages (e.g., cCTD M2.5, M2.7 and M5 etc.).
  • Support the clinical sections of INDs/NDAs/BLAs/MAAs to ensure proper presentation of statistical analyses and results.
  • Support regulatory documents such as briefing book, and regulatory meeting as needed.
  • Review CRFs, and work with data managers on DMPs, data edits check, etc.
  • Contribute to the development and revision of statistics SOPs.

Qualifications and Skills
  • MS or PhD degree (strongly preferred) in statistics or biostatistics
  •  8+ years’ statistics experience, with at least 5 years of biostatistics in the pharmaceutical/biotech industry
  • Strong basis in statistical concepts and expertise in statistical methodologies in clinical trials
  • Strong statistical programming skills with SAS and R, experience with sample size software such as EAST
  • Familiar with CDISC requirements for SDTM and ADaM
  • Ability to provide support/contribute to integrated clinical, regulatory and safety discussions, thinking broadly beyond biostatistics
  • Strong communication and collaboration skills.  Ability to communicate concepts clearly and concisely verbally and in written form to broad audiences inside and outside the clinical team
  • Ability to work on multiple projects simultaneously

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

More about Rhythm
Our lead asset, IMCIVREE® (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE® is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.

We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE® to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.  
 

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