Associate Director, Biostatistician
|Date Posted||January 16, 2023|
|Job Status||Not Specified|
Syndax Pharmaceuticals is looking for an Associate Director/Principal Statistician – Biostatistics
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
Play an active role in designing efficient trials and conducting clinical, PK/PD, and biomarker data analyses, serve as a key member on clinical trial teams, and provide statistical support to study conduct, analysis and reporting. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver.
- Play an active role in designing efficient clinical trials
- Collaborate with clinical trial team to support study conduct, analysis and reporting
- Serve as an influential statistical consultant to medical and development team
- Independently conduct clinical trial simulations
- Independently perform clinical, biomarker, and PK/PD data analyses
- QC and interpret clinical trial results
- Write statistical analysis plans, statistical sections of protocols, and reports
- Review relevant medical literature
- Help develop protocols, case report forms, and clinical study reports
- Develop TLF shells and review programming specs
- Engaged in clinical data review for data quality and integrity
- Act as an integral member of project team, collaborate effectively with other team members, and attend project team meetings
- Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
- Conduct quality review of statistical analyses; conduct ad hoc analyses if needed.
- Keep updated with regulatory requirements
- Support interactions with regulatory authorities
- Provided oversight to biometrics vendors
Desired Experience/Education and Personal Attributes:
- Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience
- Profound understanding of advanced clinical trial design and statistical analysis methodologies
- Good understanding of the big picture of an overall development program
- Capable of thinking strategically
- Excellent communication and interpersonal skills
- Ability to lead project teams, as well as work in a cross-functional team
- Strong ability to quickly capture key information from medical journal articles
- Understand regulatory requirements and good clinical practice guidelines
- Ability to multitask and prioritize work
- Good statistical programming skills using SAS and other statistical software
- Good leadership and consultation skills
Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States. Regular travel will be required for this role. To help ensure the safety and well-being of our employees, visitors, and other stakeholders, Syndax strongly encourages employees/consultants to get vaccinated/boosted against COVID-19 prior to participating in an in-person meeting or traveling on behalf of Syndax.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.