Director of Biostatistics
Director of Biostatistics
JOIN a fast-growing Mid-Sized international pharmaceutical firm in the Bay Area as their Director Of Biostatistics – Excellent European based employer has a superb work environment – This is a key position for the firm.
The Director of Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Independently provides strategic statistical input to drug development planning, including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions, and follow up. Contributes to establishing and driving strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Medical, Clinical Scientists, Data Management, Clinical Operations, Safety, and Regulatory teams providing overall statistical leadership, direction, and consulting as it relates to the design, analysis, and reporting. Represents biostatistics in core project team meetings on operational and strategic decision-making related to assigned projects. This individual is also 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, or performing the work themselves.
The Director of Biostatistics will report to the Executive Director and work closely with the Clinical team.
Key Duties and Responsibilities
- Act as the primary contact and provide oversight for all biostatistics related activities
- Work closely with colleagues (Medical, Clinical Scientists, Data Management, Statistical Programmers, Medical Writing, Safety, Clinical Operations, and Regulatory teams) to:
- Review protocols and prepare statistical methods section(s), including sample size estimation and clinical endpoint assessments, to ensure client conducts well designed, efficient, cost-effective as well as statistically valid clinical trials
- Generate and/or review randomization schedule(s) to ensure there are no errors and protocol requirements are met. Perform ongoing monitoring of actual randomization scheme
- Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications
- Prepares and/or reviews detailed Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of a formal statistical analysis report
- Ensures proper closeout and archiving of study related materials, i.e. randomization lists, datasets, programs, specifications, macros, etc.
- Lead and manage external (and/or internal) biostatistics and statistical programming resources supporting studies and programs
- Build in-house statistical and programming department to support those activities as company expands and grows
- Develop Standard Operating Procedures, work instructions, guidelines, data standards, and processes as needed to govern the biostatistics group and deliverables
- Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
- Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions
- Leverage standardization to maximize global data integration and interpretability
- Retrieve and understand regulatory requirements regarding submission of clinical data to various agencies (e.g., CDISC SDTM, ADaM, Define.xml, Reviewer’s Guide, via eCTD) and provide CRO oversight in ensuring deliverables meet project needs, standards, and expectations
- Responsible for providing statistical leadership for preparation of marketing applications (BLA) to FDA, EMA, PMDA, or other worldwide regulatory agencies
- Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
- Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs
Desired Education, Skills, and Experience
- A PhD in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience
- Comprehensive knowledge of statistical methodology in design and analysis of clinical trials
- Experience with regulatory requirements relating to clinical development of drugs
- Excellent knowledge of major statistical software programs including SAS
- Excellent knowledge of CDISC submission requirements regarding
- Excellent verbal and written communication skills, and excellent inter-personal skills
- The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize
- Supervisory experience
Job Status: Full Time