Associate Director Biostatistics
- R+D/ Global Development Support
- San Diego area
- Salary range: $160-200k base, bonus + additional benefits
An exciting late-stage biotech company persistently dedicated on translating drug innovation and research into new remedies for patients by developing and distributing innovative therapeutics that target the genetic and immunologic drivers of cancer is looking to hire an Associate Director Statistics. This position is accountable for leading several clinical studies, offering statistical provision on study design and all aspects of study conduct, including but not limited to author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity.
The AD Biostatistics position will have responsibilities that include:
- Embodies Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
- Authenticate the outcomes of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
- Management of vendors to ensure timeliness and quality of analysis and statistical outputs
- Operate independent statistical modeling and simulation or in cooperation with other team members to assist drug development strategy
- May perform submission related activities, represent department in meetings with regulatory agencies
- Support publications effort including manuscripts, conference presentations and posters
The ideal candidate will have the following skill set:
- A PhD in statistics, biostatistics or related field with minimum of 6 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 8 years of experience;
- Innovative/expert knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
- Exhibited written and excellent communication and interpersonal skills, with the capacity to translate statistical concept into layman's terms
- Demonstrated leadership skills
- Proficiency with statistical programming in SAS and/or R
- Knowledgeable in CDISC standard including SDTM, ADaM
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
Preferably BLA/NDA experience including eCTD submission
