Senior Manager, Biostatistics

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/20/18
Cambridge, MA
5 - 7 years experience
Salary depends on experience
Posted on 03/20/18

Senior Manager, Biostatistics

Clinical Development  Cambridge, MA

Apply

Description

Who are we? Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company’s leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body’s ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension. What’s in it for you? Reporting to the Vice President of Biostatistics and Programming, you will work with a cross-functional team and provide Biostatistics support to ensure that the statistical considerations are optimally planned, properly analyzed and clearly presented. You will lead the biostatistics activities for at least one of our exciting and developing programs as well as aid the greater Biostatistics group with other projects. What will you be doing?

  • Proactively working with study team and providing appropriate statistical consideration
  • Providing input for statistical activities in clinical studies, including design, analysis and scientific interpretation
  • Managing the statistical deliverables such as protocol statistical section, SAP, TLF (Table/Listing/Figure), ad-hoc statistical analysis and CSR
  • Working closely with programming team and providing statistical inputs for ADaM datasets derivation and Table, Listing and Figure outputs
  • Proactively working with CRO, providing guidance and resolving statistical issues on a timely basis
  • Tracking and being accountable for the quality and timeline of the statistical deliverables
  • Providing inputs and implementing standard operating procedures for statistical function including best statistical practices and QC standards
  • Working with team closely to perform statistical analysis, as needed for a variety of deliverables such Interim analysis, CSR, regulatory briefing document, abstracts, posters, and manuscripts
  • Managing verbal and written requests for ad hoc data outputs and proactively work with the requestor for clarification as needed to generate the requested outputs
  • Multi-tasking and managing multiple studies/programs and delivering on-time and withquality
  • Staying current with new applicable statistical methodology and regulatory guidance   

What are we looking for?

  • Ph.D. degree in statistics
  • Approximately 4-8 years of experience in a Pharmaceutical, Biotech or CRO setting
  • Strong statistical methodology background and proper application to daily work
  • Highly experienced with SAS and/or R and strong capability for detailed, hands-on statistical analysis; Ability to plot figures with R is a big plus
  • Experienced with CDISC standard including SDTM and ADaM. Previous regulatory submission experience is a plus
  • General familiarity with all phases of drug development and regulatory requirements
  • Solid interpersonal and teamwork skills
  • Excellent organizational skills and good verbal and written communication skills
  • Ability to work independently
Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.