My client, a growing Biotech, is looking for a Senior Director of Biostatistics to join their team who is passionate about making a difference in people's lives. In this role, you will lead the statistical analysis of their clinical studies and work closely with cross-functional teams to provide expert biostatistical input on development plans, regulatory interactions, and study design across Immunology & Inflammation. You will have the opportunity to shape the future of healthcare and work in a fast-paced, highly dynamic environment. All positions offer the flexibility to work remotely. If you are someone who is driven by the desire to make a positive impact and grow professionally, then this is the perfect opportunity for you!
Key Responsibilities:
- Lead the statistical analysis of clinical studies
- Provide expert biostatistical input on development plans, regulatory interactions, and study design
- Oversee and lead the vendor/CRO biostatistics teams
- Evaluate alternative or innovative approaches to statistical methods and study design
- Build relationships with CROs and other external partners to achieve results for specific project needs
- Ensure the delivery of high-quality and timely reports to project teams and clinical trial team
- Work closely with the Head of Biometrics to develop and maintain statistical/programming policies, guidelines, and procedures (SOPs, training manuals, etc.)
Ideal Candidate
- PhD in statistics
- A minimum of 10 years' experience working at a Biotech or Pharma
- Very Strong FDA Submission & Indication Lead experience
- Experience leading teams and working in a matrix organization
- Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
- Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
- Experience managing CROs and other data vendors
- Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment
- Knowledge and proficiency in SAS or R and other industry computational tools
- Knowledge of CDISC standard including SDTM, ADaM
- Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
- Strong leader with a growth mindset
What they Offer:
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- Flexible PTO
- Two, one-week company-wide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
If you are interested in learning more, apply today!
