Sr. Manager, Biostatistics ** Do you want an expansive BioStats role with mentoring and growth opportunities? Join a Leader in Rare Diseases - TAs Onc/Hemo & Neuro ** Locations in Bridgeport & Stamford, CT

Reference: 9879

Expiry Date: 31-03-2024

Categories Biotech, Clinical Research, R & D

Salary: Competitive

Job Type: Full Time

Location:
New Haven County
United States

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Job Description

Sr. Manager, Biostatistics ** Do you want an expansive BioStats role with mentoring and growth opportunities? Join a Leader in Rare Diseases - TAs Onc/Hemo & Neuro ** Locations in Bridgeport & Stamford, CT * 

Location: Locations in Bridgeport & Stamford, CT - Please note our role is Hybrid so part office part home, expected to be in weekly at their site.

Summary

Our client is a rare disease-focused mid-sized company with almost 3000 employees worldwide and a turnover almost hitting USD 7 billion. They have an extensive pipeline with of NMEs and line extensions in development and already have 5 approved medicines.  They are financially stable with plans for further expansion and growth across their key therapeutic areas and they offer job security, strong values, and career growth opportunities.

This role is an exciting opportunity to be a critical part of the clinical development group of a high-growth organization. The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies for clinical programs in the rare disease space. This position will report directly to the Vice President and Head of Biostatistics and work across several interesting therapy areas including Oncology, Hematology and Neurology, through all stages of development.

The working model is Hybrid, so a good mixture of office-based and remote working and you will receive a highly competitive package including a good stock plan, excellent benefits and an extensive holiday allowance much higher than most other East Coast Biotech’s.

The Role

  • Serve as the biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time.
  • Responsible to bring innovative statistical thinking and operational excellence to help drive applications of state-of-art statistical methods that increase the probability of successes for clinical development programs.
  • Develop statistical sections of protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.
  • Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence.
  • Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
  • Consults with Research & Preclinical colleagues on statistical questions in their work.
  • Manages CRO statistical and programming support.

Experience needed:

  • PhD in statistics (or equivalent degree) with 4+ years or master's with 7+ years of relevant working experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
  • Excellent statistical knowledge with the ability to apply the knowledge to solve scientific and clinical problems.
  • Working knowledge of relevant ICH guidelines, US, EU and other regions’ regulations.
  • Experience working on oncology or rare disease clinical studies and regulatory interactions are preferred.
  • Familiarity with R programming language and other statistical software, including EAST.
  • Experience with CDISC, including SDTM, ADaM, CDASH.

To Apply!

Please click the “Apply for position” red box or get in touch with me, Theo Moore at Theo@AdvTalent.com or call directly at 587.216.9302.