Snr Manager, Biostatistician ** Join a growing Biotech in Rare Diseases ** Great Salary and Package ** Varied TA's ** Early & late Phase Projects **Boston, MA & sites in Southern Connecticut
Location
Suffolk, VA | United States
Job description
Job Description
Snr Manager, Biostatistician ** Join a growing Biotech in Rare Diseases ** Great Salary and Package ** Varied TA's ** Early & late Phase Projects **
Location: Boston, MA & sites in Southern Connecticut
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 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.
- For Biostatisticians they offer real career roles with multiple project and promotion options!
Why Join?
- This is an exciting opportunity to be a critical part of the clinical development group of a high-growth organization that is seen as one of the leading lights in successful rare disease drug development.
- The Senior Manager / Principal Biostatistician will be involved in the design, execution, analysis, and reporting of clinical studies for clinical programs in rare diseases including Oncology, Hematology and Neurology, through mid and late development and for marketing authorizations.
- This position will report directly to the Vice President and Head of Biostatistics who will mentor, support, and offer advice and training so you can make the step up to Associate Director grade.
- 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 can offer.
The Role:
- You will be responsible for bringing 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.
- Operate as a lead biostatistician in clinical development teams responsible for all clinical study biostatistics deliverables with high quality and on time.
- 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.
- Participate in other activities and meetings to support Biostatistics and the Global Program Team as needed.
Experience needed:
- Ph.D in statistics (or equivalent degree) with 4+ years or master's with 6+ 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.
Location:
- Boston, MA & sites in Southern Connecticut.
- Roles are Hybrid with the expectation to be in the office 1-2 days a week.
- If you are based outside of Massachusetts, the role comes with a full and comprehensive relocation package.
To Apply!
If you are interested in applying or would like to hear more about this position, press the “Apply Here” button or please contact me (Theo Moore) via email at [email protected] call directly at 587.216.9302.
We look forward to hearing from you!
Linkedin: https://ca.linkedin.com/in/theo-moore-b33696a
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