Senior Manager, Statistical Programming - Rhythm Pharmaceuticals

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. 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 a Manager or Senior Manager (depending on the experience), Statistical Programming to join our Biostatistics and Data Management team. Reporting to Director, Head of Statistical Programming, this individual will provide all statistical programming support for assigned Rhythm’s clinical studies and submission activities.

Responsibilities and Duties

• Serve as lead statistical programmer to support all assigned Rhythm’s clinical programs, and work collaboratively within Clinical Development to meet high quality deliverables and timelines for statistical programming and reporting
• Write documentation and maintain version controls on SAS programs, Macros, and specifications
• Develop/review TLFs shells and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues
• Collaborate with Data Managers to provide input on CRF design, CRF annotation, edit checks, integrated data review plans, and SDTM specifications as needed
• Contribute to the development of departmental programming SOPs and implement Good Programming Practice
• Review or contribute to study protocols, statistical analysis plans (SAPs) and TLF shells, data analysis and CSRs in collaboration with Biostatisticians, Data Managers and other functions
• Excellent knowledge on CDISC standards (CDASH, SDTM, ADaM, eSub) and Implementation Guidelines, Create/Review Define Docs, Reviewers’ Guides, OpenCDISC validation report etc. to support electronic submissions in eCTD format
• Experience in integrating datasets across multiple clinical studies (or equivalent) to support ISS/ISE

Qualifications and Skills

• MS (or equivalent) in Statistics, Mathematics, Computer Science, or related area with ~5 years of statistical programming experience
• Advanced knowledge and experience with SAS programming (SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL, SAS/ODS etc. Modules)
• Proven experience in development and standardization of advanced SAS MACROs with high programming efficiency, strong programming and problem-solving skills

This role is based out of 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

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of hyperphagia and severe obesity due to rare melanocortin-4 receptor (MC4R) pathway diseases. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.