Senior Director Biostatistics - REMOTE

Company: Penfield Search Partners Ltd
Location: Saint Louis
Posted on: January 15, 2022

Job Description:

Our client is -a leader in the translation of RNAi into a new class of innovative medicines with applications across several therapeutic areas including Rare Disease, Cardio-Metabolic, Infectious and CNS. They are currently seeking a Senior Director or of Biostatistics to provide statistical leadership and strategic input to guide the clinical development program their first internally developed prevalent disease program in Hypertension, managing the biostatistical staff and leading the Data Sciences and Statistics team on this program, and a few early phase development programs as well. This is an important and complex program with the possibility to do a lot of interesting and innovative design work.

In this role you would be accountable for the statistical design of clinical development programs including innovative clinical trials, authoring of clinical and regulatory documents, implementation and quality of statistical analyses including interpretation and communication of analytic results, support for worldwide regulatory submissions and medical affairs activities, and building efficient processes and standards to accelerate worldwide product approvals. This position will represent the function in global regulatory meetings and is responsible for resource planning/allocation, timeline management, and recruiting, retaining, managing, and mentoring Biostatisticians, including global program leads.

- - - - - - - -Promote research of advanced and innovative statistical methods
- - - - - - - -Collaborate with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials
- - - - - - - -Promote teamwork, quality, and innovation through direct or indirect leadership of Data Sciences and Statistics program team meetings
- - - - - - - -Lead Biostatistics support for worldwide regulatory submissions
- - - - - - - -Represent in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
- - - - - - - -Contribute to scientific articles, summarizing data collected and other statistical analysis to support Medical Affairs
- - - - - - - -Consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work
- - - - - - - -Build efficient processes and standards to accelerate worldwide product approvals, including authoring of SOPs
- - - - - - - -Accountable for statistical sections of clinical trial protocols, stratification/randomization schema, statistical analysis plans, and statistical contributions to eCRFs, clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
- - - - - - - -Interpret and communicate the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts
- - - - - - - -Manages internal and vendor statistical and programming support

Desired for the role:

- - - - - - - -Ph.D. in Statistics or Biostatistics or Equivalent with 12+ years in industry, or MS 15+
- - - - - - - -Some experience as a people manager, including authorship of performance evaluations
- - - - - - - -Experience in clinical development through Phase 3 (NDA submission)
- - - - - - - -Experience in developing drugs for prevalent diseases
- - - - - - - -Understanding of ICH GCP as well as general knowledge of industry best practices and standards
- - - - - - - -Experience with CDISC, including SDTM, ADaM, CDASH
- - - - - - - -Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
- - - - - - - -Interest in and basic understanding of biology and biological processes, including RNAi
- - - - - - - -Experience designing and conducting adaptive trials
- - - - - - - -Experience with Bayesian study design and analysis

Keywords: Penfield Search Partners Ltd, St. Louis , Senior Director Biostatistics - REMOTE, Executive , Saint Louis, Missouri