Senior Biostatistician I

Requirements: We are seeking a Senior Biostatistician for our clinical research client.  The candidate must have PhD in statistical science, mathematical analysis or related field with 4+ years Pharmaceutical/CRO experience or a Master's plus 7+ years relevant experience with demonstrated ability and sustained performance at the Ph.D. level .  Must havea degree from a US, Canadian or a UK university.  It would be a plus for any candidate to have oncology experience and should be well versed in SAS. 

POSITION OBJECTIVE:

This position is accountable for developing, applying and/or providing expertise in statistical and data management methods and techniques to effectively enable decision making in support of the company's mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and data management team activities for clinical trials from the development of study protocols to the completion of study reports.

May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

ACCOUNTABILITIES: 

1. Provide leadership/expertise in resolving complex problems in support of divisional/company objectives, or assigned projects, or as a consultant to others. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but are not limited to, the following:

• Providing leadership/expertise in research and development of statistical methodologies.
• Investigating and implementing new technologies, processes and procedures.
• Developing and executing marketing strategies and plans (trade shows, publications/presentations, corporate website design and maintenance, meeting with existing and new clients).
• Developing and executing customer relationship management plans.
• Participating in new business development and bidding processes.
• 2. Perform review for clinical study protocols and statistical/data management documents generated by others.
• 3. Act as Lead Biostatistician/Liaison Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.
• 4. Lead assigned projects by applying project management skills, statistical and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.
• 5. Plan, develop and monitor timelines for statistical and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and data management resource needs and manage the assigned resources.
• 6. Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS or web-based patient randomization processes for assigned projects.
• 7. Oversee the development of Data Management Plans (DMPs) for assigned projects.
• 8. Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs.
• 9. Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases.
• 10. Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures.
• 11. Oversee data management activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues.
• 12. Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.
• 13. Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects.
• 14. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
• 15. Participate in evaluating the performance of assigned project personnel.
• 16. Follow up on the development and implementation of new statistical and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices. May provide specialized training in an area of technical, professional or business expertise.
• 17. Participate and contribute to the training and development of new biostatisticians.
• 18. Lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines.
• 19. Lead efforts in the development, maintenance and adherence to therapeutic area specific standards and conventions, and be the primary knowledge holder of sponsor specific requirements.
• 20. Lead efforts in the development, maintenance and adherence of Corporate policies and SOPs.
• 21. Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
• 22. Plan and carry out professional development.

The weight for each of the above accountabilities/duties will depend on the size of the Statistical Sciences and Project Management division/the company. When the size is small, more weight will be put on hands-on project management and statistical work; when the size is bigger, more weight will be put on supervisory and business management work.

For new Biostatisticians to the company, SAS training in the local programming environment will be provided by the internal SAS programmers. Intensive SAS programming for statistical analysis and the generation of statistical tables, listings, and graphs will be a requirement for the first year on the job.

MAJOR DECISIONS WITHIN THE INCUMBENT'S AUTHORITY LEVEL:

• 1. Contributes to business/scientific/management decision making process.
• 2. Contributes to strategic approach to development programs and statistical/data management projects.
• 3. Decisions regarding work-flow and priorities to meet divisional and corporate priorities.
• 4. Decisions resulting in solutions to scientific, technical, operational and developmental problems posed by project teams and management.
• 5. Decisions relating to the guidance of statistical/analysis and training requirements of junior personnel.

DECISIONS REFERRED TO THE NEXT LEVEL OF MANAGEMENT:            

• 1. Decisions relating to priorities of projects and development programs.
• 2. Decisions relating to the allocation of resources to projects.
• 3. Decisions relating to professional developmental plan.
• 4. Decisions relating to the finalization of corporate business development and marketing plans.

KEY EQUIPMENT/SOFTWARE USED:

• 1. Microsoft Word, PowerPoint, Excel, Outlook.
• 2. DataFax.
• 3. ORACLE.
• 4. SAS.

Please email your resume and cover letter to ruth@pharmacruiting.com

Pharma-Cruiting is a dynamic boutique executive recruitment firm specializing in the recruitment of mid and senior-level executives through C-Suite positions (e.g., CEO, COO, CFO, CSO, CMO) within the Life Sciences industries.  We provide recruitment expertise in the most sought after areas, including (but not limited to) Pharmaceuticals, Biotechnology, Medical Devices, Diagnostics, Health, Genetics and Genomics throughout the United States and internationally.  Our headquarters are in Greater Philadelphia with offices located throughout the United States. 

With over 15 years of industry experience, Pharma-Cruiting has achieved the level of expertise and experience necessary to successfully place elite executive talent giving companies a competitive edge and helping world-class professionals accomplish their dreams.

• We distinguish ourselves by "Recruiting only the Elite".
• Our accumulation of industry knowledge, expertise and extensive network of contacts has created sustained working relationships to enable us to create the perfect match for you.
• We deliver exceptional, strategic, comprehensive, and client-focused personalized services.
• Our strength is delivering the best and brightest talent aligned with your diversity and inclusion workforce goals.
• Professionalism, integrity, excellence in execution and customer satisfaction are our highest priority. 

• Contact Pharma-Cruiting today for all of your recruitment needs: 

  215-485-2156  or email at   info@pharmacruiting.com