(Senior) Director* Biostatistics - REMOTE
Proclinical is seeking a remote (Senior) Director* Biostatistics for a cutting-edge biotech company.
Must be eligible to work in the US.
- Serve as the Biostatistics lead core team member for all assigned programs and holds themselves accountable for all statistical aspects. Represent Biostatistics in cross-functional project and study teams on multiple projects
- Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents (including ISE/ISS), and publications ensuring accurate deliverables
- Generate and/or verify sample size calculations and randomization schemes as needed. Lead development of statistical analysis plans and TLF development and perform statistical analyses and validate analysis results using SAS or R software
- Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
- Be responsible for vendor management and oversee outsourced statistical CRO activities and deliverables ensuring highest quality in a timely manner
- Support and participate in the development of departmental strategies, and cross functional initiatives on standards, infrastructures, and processes
- Develop, improve, and implement statistical processes and standards
- Ensures operational and functional excellence, constantly evaluating and implementing new technologies, and leveraging state-of-the-art analytical tools
- Assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent
Skills and Requirements:
- PhD or masters in (Bio)statistics or Mathematics
- Minimum 10 years (12 years for masters) in the pharmaceutical industry and/or CRO
- At least 5 years of work/leadership experience, overseeing statistics staff (internal, external, or outsourced) and in representing Biostatistics in a matrix organization and multidisciplinary team
- Experience in planning, conducting and analyses of oncology or infectious disease trials from phase I-IV, including scientific publications
- Experience in supervision of outsourced activities as well as with the development and execution of outsourcing strategies
- Experience in answering health authority questions (FDA, EMA) and in leading statistics on regulatory submissions, including developing ISE/ISS packages
- Excellent knowledge of clinical study designs, statistical methods (adaptive/non-inferiority designs/analyses, and Bayesian a plus), regulatory guidelines (ICH, FDA, EMA)
- Excellent knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
- Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
- Ability to thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient
- Excellent interpersonal skills, strong teamwork spirit to develop good working relationships with key stakeholders. Good conflict management and negotiation skills
- Good communication skills: the ability to express complex analyses in clear language o an excellent command of English (written and spoken)
If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at +(1) 323-306-2409 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.