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Director, Biostatistics

Posted on Apr 6, 2021 by ChemoCentryx

Mountain View, CA 94042
Research
Immediate Start
Annual Salary
Full-Time


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 to build a top biometrics function. 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.


Essential Duties and Responsibilities:



  • Provides biostatistics support to expanding portfolios.

  • 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.

  • Work closely with colleagues (Medical, 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 selection, to ensure conducts 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.

    • Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed

    • 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 clinical study report

    • 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.

    • Lead the study unblinding and validate TLFs post database lock.

    • Lead and manage external (and/or internal) biostatistics and statistical programming resources supporting studies and programs.

    • 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, TLFs, study reports, manuscripts, and regulatory submission documents.

    • Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.

    • Independently complete submission of clinical data to various agencies (eg, CDISC SDTM, ADaM, Define.xml, Reviewers Guide, via eCTD) and provide CRO oversight in ensuring deliverables meet project needs, standards, and compliance.

    • Responsible for providing statistical leadership for preparation of marketing applications to FDA, EMA, or other worldwide regulatory agencies.



  • Keeps abreast of literature/advancements in science/medicine/technology/statistics/standards in own and related fields of the drug development programs.


Requirements



  • A PhD in Statistics/Biostatistics

  • 10+ years of clinical development and analysis and reporting experience within the biotech/pharmaceutical industry depending on the positions qualifies and 3+ 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.

  • Experience in leading development and optimization of Biometrics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices.

  • Comprehensive knowledge of statistical methodology in design and analysis of clinical trials.

  • Experience in implementing innovative study designs and novel statistical methodologies.

  • Deep knowledge in clinical development including regulatory requirements in multiple regions.

  • Excellent programming skills of SAS or R.


Preferred Experience


  • Track record of successive clinical trial designs/analysis in biotech/pharmaceutical industry setting and hands-on statistical analysis experiences.



Reference: 1152693747

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