Role SummaryThe Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting 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 is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.
Key Responsibilities- Lead the biometrics team including statistician, data manager, and statistical programmer at a program level
- Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies
- Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies
- Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings
- Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data
- Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
- CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines
- Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
- Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses
- Build and develop efficient biostatistical processes and standards, when appropriate
Ideal Candidate- PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.
- Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology is preferred.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Proficiency in statistical software (e.g., SAS, R) and data management systems.
- Experience with CDSIC including SDTM, ADaM, CDASH
- Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
- Excellent communication and interpersonal skills, along with organizational skills.
- Ability to work collaboratively in a multidisciplinary team environment.
What We Offer- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $ 275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
