Associate Director/Director, Biostatistician
Company: Kura Oncology, Inc.
Location: Boston
Posted on: May 2, 2024
Job Description:
ESSENTIAL JOB FUNCTIONS:
The Associate Director/Director Biostatistics is responsible for
providing technical leadership and biostatistical support to
Clinical Development through the design and conduct of clinical
studies; review and accuracy of clinical data; the evaluation,
interpretation, and reporting of study results; and regulatory
submissions to the FDA and other regulatory agencies.
- Independently leads the development and execution of
statistical aspects for multiple complex clinical trials, including
contribution to study trial design, analysis planning, study
results presentation and interpretation, clinical study report
authoring, regulatory submissions, and publications.
- Participates in establishing and maintaining policies,
standards, and procedures for biostatistics and programming
activities.
- Reviews or authors statistical analysis sections of protocols,
statistical analysis plans (SAP), clinical study reports (CSR),
regulatory documents or scientific publications, generates or
reviews study randomization, sample size/power
estimations.
- Review CRF's to ensure analysis data items are included and
appropriately captured.
- Review of data validation checks to ensure analysis variable
cleaning expectations are included.
- Review of TLF Shells and TLFs.
- Review of SDTM and/or ADaM programming specifications. Review
of vendor data transfer specifications for that data will be
included in SDTM.
- Creation of a Study Data Standardization plan by program/
indication.
- Ad hoc review of displays in support of publications/meeting,
IDMB.
- Manage timelines for creation/review/approval for
stats/programming activities (SAP, SDTM, TLFs Shells, final
TLFs).
- Provides statistically sound scientific methodology
experimental design and data analysis input to meet project
objectives and FDA (and other regulatory agencies) statistical and
data requirements in a clear, concise, complete, and transparent
manner that provide influence on key development
decisions.
- Develops statistical programs to perform pre-specified or
ad-hoc analyses and prepare data displays.
- Performs and reports study results of statistical analyses to
provide interpretation of data and sound study
conclusions.
- Provides leadership to the organization in evaluating
alternative or innovative methods of analyzing and interpreting
data, evaluates implications for study design.
- Takes accountability for ensuring quality in all planning,
design, and execution of assignments associated with the assigned
protocol or project.
- Performs other duties as assigned
JOB SPECIFICATIONS:
- Ph.D. degree in statistics and 7+ years of experience (or
master's degree in relevant statistics field and 10+ years of
clinical trial experience) in the pharmaceutical or biotech
companies, or related experience or equivalent combination of
training and experience.
- Proven knowledge and expertise in statistics and its
applications to clinical trials.
- Team player, with ability to work successfully across
functions.
- Demonstrated written and excellent communication and
interpersonal skills, with the ability to translate statistical
concepts into layman's terms.
- Demonstrated leadership skills.
- Proficiency with statistical programming in SAS and/or
R.
- Knowledgeable in CDISC standards, including SDTM,
ADaM.
- Familiar with ICH guidelines, FDA, and other regulatory
authority guidance.
- Preferably NDA experience, including eCTD submission.
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Keywords: Kura Oncology, Inc., Medford , Associate Director/Director, Biostatistician, Executive , Boston, Massachusetts
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