The Senior Director, Biostatistics will help continue advancement of our clinical pipeline in immunotherapy and will actively support clinical development programs as its lead biostatistician. The Senior Director will collaborate with other leaders and groups on development approach, will recommend appropriate statistical strategies to clinical leadership, and will be responsible for ensuring data analysis and statistical reporting across programs are high quality and meet the requirements of global health authorities.
Location: NJ/CT/MA Remote, travel required to NJ and CT
- Provide high level of statistical input to efficiently support complicated study designs.
- Prepare statistical consideration section and provide input into other protocol sections.
- Write Statistical Analysis Plans (SAPs).
- Support regulatory requests and potential filings and support potential partnering requests.
- Responsible for all deliverables related to statistical content.
- Plan and execute clinical trial data analysis and reporting; ensure adherence to timelines and quality output.
- Oversee programmers to provide tables, listings and graphs, as well as ad-hoc analyses; may participate in programming as necessary to accomplish objectives.
- Establish and enforce processes to ensure validation of all deliverables.
- Support in developing standardized macros.
- Review, synthesize and interpret analysis results, and provide statistical input for preparation of required documents including final study reports, publications, and regulatory submissions.
- Supervise internal and external team members.
- Stay abreast of statistical developments, methods, and technologies related to the Biotech/Pharmaceutical industry.
- Make strategic and tactical recommendations to provide and ensure competitive advantage to the company.
- Strong statistical experience in clinical drug development, especially in immune-based disorders (allergy, immunology), in a Pharmaceutical/Biotech/CRO setting. Experience in oncology is desirable.
- Demonstrated proficiency in the design of clinical trials Phases I – III
- Experience with analysis of patient reported outcome data.
- Experience working with DSMB for clinical trials
- Demonstrate skills in the analysis and reporting of clinical trials.
- Experience with integrated summaries of safety and efficacy (ISS and ISE)
- Strong knowledge of clinical trial design concepts, clinical drug development process, statistical methodologies and statistical regulatory requirements including ICH and CDISC.
- Excellent programming skills and extensive experience with statistical computing software (e.g. SAS).
- Prior experience as statistical representative in interactions with regulatory and health authorities considered a plus.
- Experience in managing, developing, and motivating professionals, including external consultants and contract research organizations
- Excellent interpersonal, communication, writing and organizational skills.
- Experience working in a cross-functional team environment.
- PhD required
- 5+ years of experience as a Biostatistician.
- 5+ years experience in Pharma/Biotech
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