Rhythm Pharmaceuticals Manager, Statistical Programming in Boston, Massachusetts
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. Working at Rhythm means that you are part of a team that?s passionate about transforming the lives of people living with rare genetic disorders of obesity. 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.
Rhythm is seeking a Manager, Statistical Programming to join our Biostatistics and Data Management team. This individual will report to Associate Director, Statistical Programming, and provide the statistical programming support for assigned clinical studies.
Responsibilities and Duties
Serve as lead statistical programmer to support assigned clinical studies and work collaboratively with Clinical team 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 Management, and other functions.
Qualifications and Skills
Bachelor's degree, MS (or equivalent) in Statistics, Mathematics, Computer Science
A minimum of 5+ years relevant statistical programming experience in the biotechnology, pharmaceutical or medical device industries.
Strong hands-on skills in statistical programming.
Excellent knowledge on CDISC standards (CDASH, SDTM, ADaM, eSub) and Implementation Guidelines, Create/Review Define Docs, Reviewers? Guides, Pinnacle 21 report etc. to support electronic submissions in eCTD format.
Experience in integrating datasets across multiple clinical studies (or equivalent) to support ISS/ISE.
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 in our Corporate office in Boston, Massachusetts. Candidates applying must be willing and able to be in the Boston office once it is safe to do so, per State and Federal COVID-19 guidelines.
More about Rhythm
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. 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 disorders 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 genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, please visit www.UNcommonObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.