Associate Director/Director, Biostatistics

Bioanalytical Development Cambridge, MA


Description

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 work with project team and provide statistical consideration for clinical development plan at the compound level
  • Manage statistical activities for clinical studies including design, analysis and scientific interpretation
  • Accountable for statistical deliverables such as the protocol statistical section, SAP, TLF (Table/Listing/Figure), ad-hoc statistical analysis and CSR
  • Work closely with the statistical programming team and provide statistical inputs for Table, Listing and Figure outputs.
  • Effectively manages the outsourcing work of statistical deliverables to CRO. Provides guidance, critically reviews outputs and resolves statistical issues on a timely basis.
  • Accountable for the quality and timeline of the statistical deliverables
  • Provide input and implement standard operating procedures for the statistical function including best statistical practices and QC standards.
  • Independently performs statistical analyses as needed for a variety of deliverables such as interim analysis, CSR, regulatory briefing document, abstracts, posters, and manuscripts.
  • Manage 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-task and manage multiple studies/programs and deliver on time and with quality.
  • Stay current with new applicable statistical methodology and regulatory guidance.  

What are we looking for?

  • M.S. or Ph.D. degree in statistics; Ph.D. preferred
  • A minimum of 5 years (Ph.D.) and 8 (M.S.) of experience in a Pharmaceutical or Biotech 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;
  • 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

How will you grow with us?

You will be joining Acceleron at a time of growth and exciting activity.  Our robust pipeline and advancing programs will challenge and motivate you to learn and develop in a fast-paced environment.  You will be a part of a supportive group who will support you and value your innovative ideas and contributions.  Join our team and help us achieve our mission of transforming the lives of patients!

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com

 

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit https://acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.