Associate Director, Biostatistics
At Constellation we know that our success as a company lies in the hands of individual employees across every element of our company working together. To foster this success, we strive to create a diverse, challenging, exciting, and fun work environment for all employees. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.
The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.
This will become an onsite position reporting to the Senior Director, Biostatistics.
How you will spend your day:
- Collaborating with Clinical Research, Regulatory Affairs, and Clinical Operations Expertise Areas to design clinical trials.
- Writing the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Contributing to or preparing statistical analysis plans.
- Collaborating with Data management, Clinical Research, and Clinical Operations on design of eCRFs.
- Providing statistical guidance on conduct of ongoing clinical trials.
- Collaborating with Statistical Programmers on summary and analysis of trial data.
- Contributing to clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.
- Contributing to scientific articles, summarizing data collected in Constellation clinical trials.
- Participating in other activities and meetings to support Biostatistics and the Development Team as needed.
- Consulting with Research & Preclinical colleagues on statistical questions in their work.
- Managing CRO statistical and programming support.
Key Things About You:
- You have a PhD in Biostatistics, Statistics, or Equivalent with at least 5 years pharmaceutical biostatistics experience or MS with at least 8 years of relevant experience
- Excellent written and oral communication and presentation skills
- Experience programming in SAS
- Working knowledge of FDA, EMA, and ICH regulations and guidelines
- Familiarity with sample size software such as nQuery or EAST
- Experience with CDISC, including CDASH, SDTM, and ADaM
- Experience in oncology preferred
- Experience in NDAs, MAAs, or other regulatory submissions a plus
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Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.