Senior Manager / AD Biostatistics
Proclinical is currently recruiting for a Senior Manager of AD Biostatistics for a leading biotechnology company located remotely. As the AD Biostatistics Senior Manager, you will assist the clinical team in designing all sponsored clinical trials and prepare all statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
- Review database design, CRF's, and edit checks.
- Prepare statistics sections for the clinical stud protocols and statistical analysis plans.
- Prepare statistical sections for relevant background documents for EU, Africa, and U.S. regulatory agencies.
- Write specifications to create CDISC data sets, tables, figures, and listings.
- Provide programming support to programming team when it is needed for the validation of clinical study tables and listings.
- Provide effective guidance to Programmers; good team player; good business ethics; good leadership skills.
- Effectively manage one's projects, and also meets deadlines while maintaining high quality standards.
- Explain statistical designs and concepts to non-statisticians.
- Other duties as requested to meet company milestones including support for Clinical Immunology department.
Skills and Requirements:
- Master's degree in Statistics (or equivalent degree) with at least 6-8 years of relevant experience or PhD in Statistics with at least 4-6 years of relevant experience; experience gained in the main tasks of a Senior Statistician (about 2-4 years).
- Knowledge of experimental design for clinical trials, power calculations, survival analysis and other methods for assessment of efficacy, and linear models.
- Familiarity with current ICH guidance pertinent to clinical development.
- Proven knowledge and expertise in biostatistics and its application to vaccine clinical trials; solid knowledge and experience in vaccine development process, including evaluation of epidemiologic data for definition of key endpoints and assessment of correlates of risk.
- Able to thrive in a fast-paced team environment, and also work independently on projects.
- Very good communication and presentation skills; ability to influence team members and communicate statistical concepts across functions.
- Thorough and up-to-date working knowledge of statistical software packages (e.g. SAS and R); hands-on programming experience; two to four years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) in a biotech or pharmaceutical company, or in a contract research organization servicing the pharmaceutical industry.
- Experience with CDISC is preferred.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or firstname.lastname@example.org.
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.