Other Locations:US- CA- San Diego- Science Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsible for collaborating with clinical pharmacology and biostatistics management on statistical strategy and for serving as the statistical lead across clinical pharmacology projects. Serves as primary biostatistician on multiple studies. Participates in the development of study designs, protocols, statistical analysis plans, and statistical strategy with regulators. Reviews CRFs, programming specifications, and data management plans. Performs statistical analysis, interprets statistical results, participates in the preparation of clinical study reports, and participates in regulatory interactions. Oversees the work of CROs that are performing any of the above listed tasks. May have direct reports. May travel up to 20%.
Responsibilities and Duties:
- Lead the statistical strategy for clinical pharmacology across multiple development programs;
- Represent Receptos in interactions with regulatory authorities as they pertain to statistical issues
- Participate in study design and protocol development;
- Ensure that study designs are consistent with study objectives and are optimal within study constraints;
- Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios;
- Propose methods for statistical analysis and write the statistical sections of study protocols;
- Review and consult on CRF design and database edit checks;
- Review programming and analysis specifications;
- Prepare randomization schedules;
- Write statistical analysis plans and prepare table shells. Ensure that tables, listings, and figures address the objectives of the study;
- Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data;
- Lead the study and/or project teams in the review, and discussion, of analysis plans;
- Interpret statistical results and present study findings to the teams, senior management, and in various external forums;
- Participate in organizing and writing results for primary publication; and
- Maintain project files that ensure adequate and clear documentation of statistical analyses.
- Other responsibilities as assigned.
- Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation.
- Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.
Knowledge, Skills, Abilities and Qualification Requirements:
- Master's degree or Ph.D. in statistics, biostatistics, mathematics, or related field;
- 12 years of prior experience in a drug-development environment;
- Experience and knowledge of statistical design and analysis of clinical pharmacology/Phase 1 studies
- Experience with managing direct reports and contract personnel;
- Experience or training with a wide-range of skills including SAS programming and other relevant statistical software, statistical methodology and theories, and analysis;
- Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel;
- Experience writing technical documents, reports, and presentations;
- Ability to manage multiple and diverse issues;
- Key Competencies:
- Professionalism and customer service orientation
- Communication skills - written and verbal
- Planning, organizing and multi-tasking
- Prioritizing and time management
- Problem assessment and problem solving
- Information gathering and information monitoring
- Attention to detail and accuracy
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.