Principal or Director Biostatistics

Job Title: Principal or Director Biostatistics

Job Number: 33325

Location: Remote, 

Job Description

Provide biostatistical leadership for all clinical research projects, contributing to statistical analysis plans, protocols, clinical study reports, FDA/MHRA/EMA/PEI briefing books and other submission documents. Includes oversight of CRO statistical and data management work and interaction with internal teams and external statistical consultants. May participate in publications development led by Clinical Research or Medical Affairs functions. This role will be the 1st internal Biostatistician, no immediate (internal) direct reports in place and will need to be strong individual contributor and subject matter expert.

Responsibilities

Lead and manage statistical efforts for one or more studies which could be pivotal studies.
Manages and provides oversight of CRO statistical and programming support for outsourced statistical activities as well as QC key results generated by CROs.
Collaborates on case report form designs to ensure data collection meets the study objectives and the requirements of statistical analyses.
Collaborates with CRO statistical programmers on summary and analysis of trial data.
Contributes to clinical study reports and other regulatory documents (e.g., statistical analysis plans, IND, BLA, MAA submissions, briefing documents, etc.).
Ensures accuracy, precision, efficiency, robustness in statistical planning, study design, statistical analysis, interpretation, reporting, and presentation of clinical study results.
Evaluates and interprets clinical trial data, writes reports, prepare slides and present results to internal and external stakeholders including regulatory agencies.
Takes an active role in task forces or process-improvement groups and assists in providing guidance related to biostatistics, programming, and data management.
Supports the preparation of publications, including manuscripts, abstracts posters and oral presentations.
Other duties as assigned.
Relations/Network Interacts internally with Global Clinical Research and Operations, Regulatory Affairs, Pharmacovigilance, Research and Development, Global Commercial, and Medical Affairs team members
External interactions may include statistical consultants, CRO study personnel, key opinion leaders, and employees of external regulatory agencies

Required Skills

Ph.D. in Biostatistics/Statistics or MS in Biostatistics, with 8-10+ years of experience in pharma or biotech industry
Experience as a lead statistician in pharma or biotech, experience with respiratory products ideal but not required.
Understanding of ICH GCP as well as general knowledge of industry practices and standards, including GDPR.
Proficiency in SAS Programming and other statistical software including PASS and R.
Experience with CDISC, including SDTM, ADaM, CDASH.
Prior experience with IND/BLA/NDA/MAA submissions.
Experience in writing technical and management documents, reports and presentations.
Demonstrated leadership skills.
Ability to manage and bring working teams together for common objectives.
Excellent oral and written skills.
Ability to work across projects simultaneously with impeccable time management skills.
Willingness/ability to travel domestically and internationally when required.