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Title: | Senior Biostatistician | | Description: | 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
| | When you apply, please mention that you saw this job on jobs.phds.org | | Recruiter: | 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.,
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 Contact Pharma-Cruiting today for all of your recruitment needs:
215-485-2156 or
email at info@pharmacruiting.com
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