Proclinical seeking a remote Senior Director, Biostatistics for a leading pharmaceutical company.
The Senior Director, Biostatistics is responsible for statistical consulting, strategic advice, and operational execution in drug developments. This includes but is not limited to: proposing innovative study designs, defining data analysis methodologies, implementing these methodologies, interpreting the resulting findings and crafting and communicating key messages to key stakeholders.
Must be eligible to work in the US.
Job Responsibilities:
- Provides innovative and smart direction on the statistical elements of clinical development strategy to the assigned study/program
- Ensures that statistical strategy and analyses and associated statistical programming activities support product and clinical development strategy; ensures statistical consistency across company, compliance with relevant regulatory requirements and delivery in a timely manner
- Deliver statistical contributions in the study design (elements like endpoints, subgroups, additional analyses)
- Contributes directly to, the statistical strategies including the development of Statistical Analysis Plans
- Leads and contributes to all trial-related and ad hoc statistical analyses; interprets data and provides statistical input to clinical study team(s) regarding clinical trial results, Clinical Study Reports (CSR) - including tables, listings and graphs - and regulatory submissions; contributes to publications activities, scientific presentations and promotional material
- Provides strategic guidance/direction and as required, contributes to the assessment, recommendation and implementation of the statistical data analysis methodologies that align with clinical study objectives and endpoints
- Works with cross-functional teams and acts as a Subject Matter Expert for the biostatistics function
- Performs other duties when requested.
- Conduct statistical analysis of clinical trial, prepare tables, listings, figures, and reports that comply with Regulatory Authority.
- Execute analyses, exploratory and post-hoc analyses of data from clinical trials
Skills and Requirements:
- Advanced degree (MSc or PhD) in statistics or biostatistics
- At least 5 years of relevant experience in the pharmaceutical industry
- In depth knowledge and understanding of statistical methodologies and regulatory guidelines for clinical trials
- Advanced SAS programming
- Detailed knowledge of CDISC standards (i.e.: SDTM, ADAM)
- Ability to think proactively, strategically and creatively
- Strong interpersonal skills with ability to work in a team environment as well as independently
- Ability to assimilate new information rapidly, multi-task, and work across multiple projects
- Excellent communication skills, both written and verbal, with the ability to communicate complex statistical concepts to non-statistical audiences
- Ability to work effectively in a team environment and to manage multiple projects simultaneously
- Attention to detail and the ability to prioritize tasks and meet tight timelines
If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.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.
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