We are searching for a Director, Biostatistics that will focus on an exciting portfolio of experimental and commercialized drugs.
We are working with a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. They balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
The Director will independently provide strategic statistical input to drug development planning, including feasibility assessments, development plans, complex/innovative study designs, novel statistical methodology, interpretations, regulatory submissions (NDA, MAA and JNDA) and follow up. They will work with other Biometrics functions, Data Management and Stat Programming teams. The Director is accountable for the production of biostatistics deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) biostatistics and statistical programming resources and performing work themselves. This includes providing scientific leadership, ensure high quality biostatistics deliverables and scientifically and operationally optimized execution.
Why this role is right for you
- Will work on-site in a state of the art building located in San Carlos, CA(Built this year)
- Diversity of therapeutic areas to work in
- Great Opportunity for Progression into more senior role
- First product will be launched this year
Essential Duties and Responsibilities:
· Lead development and optimization of biometric processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices.
· Provide strategies for clinical study design, endpoint selection, sample size calculations, randomization schedules, statistical analysis plans (SAP) and data interpretation in collaboration with all team members, including programmers, data manager, medical writers and clinicians.
· Evaluate and implement innovative study designs and novel statistical methodologies as appropriate across each of the therapeutic areas.
· Act as the primary contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors.
- Review protocols and prepare statistical methods section(s), including sample size estimation and clinical endpoint selection, to ensure their conducts are well designed, efficient, and cost-effective as well as statistically valid clinical trials
· Generate and/or review randomization schedule(s) to ensure high statistical quality of clinical protocols and analyses. Perform ongoing monitoring of actual randomization scheme applied by IVRS/IWRS.
· Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications. Coordinate and lead team review and consolidation of comments for SAP and mock-TLFs.
· Responsible for providing statistical leadership for preparation of marketing applications to FDA, EMA, or other worldwide regulatory agencies.
· A PhD in Statistics/Biostatistics(Recommended but not required)
· 8+ years of Biostatistics and 2+ years management / leadership experience.
· Proven competencies in interaction with health Authorities (FDA, EMA and PMDA) and eCTD (NDA/BLA) submissions.
· Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, and Study Data Standardization Plan.
· Excellent programming skills of SAS or R.
- · Track record of successive clinical trial designs/analysis in biotech/pharmaceutical industry setting and hands-on statistical analysis experiences.