Sr-Principal Statistician for Product Development and Manufacturing (PHD Required)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

• Experience in the application of statistics in product development or manufacturing 

  -Excellent English communication skills, especially related to technical/scientific issues 

  -Proficient in R and JMP, data acquisition/compilation across sources  

  -Interpersonal/teamwork and communications skills for effective collaboration  

  -Strong teamwork skills 

  -Self-management skills  

  -Degree in or strong desire to learn about chemistry, biology, engineering, and pharmaceutical science 

   

  Some Examples of Statistical Activities: 

  -Conduct data integrity reviews to ensure accuracy and traceability of data used in analyses that were previously conducted by statisticians.  

  -Verify statistical output, previously generated by a statistician, by conducting the various analyses and visualizations a second time to confirm accuracy.  

  -Provide analysis, modeling, and visualizations of data from scientific studies  

  -Analyze laboratory data to assess stability of drug substance and drug product 

  -Create stability graphs that are suitable for regulatory submission documents 

  -Compile/format data from one or more data sources 

  -Conduct testing of automation tools as part of computer system validation 

  -Co-author technical reports 

   

General Experience:

Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
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Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
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Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
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Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
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Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
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Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other statisticians in the department.
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Implements company objectives, and create alternative solutions to address business and operational challenges.
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Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
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Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP and specifications.
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Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitor progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.
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Provides statistical programming support as needed.
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May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
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Leads projects involving integrated analyses, attends regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
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Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g. International Conference on Harmonization (ICH).
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Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
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Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
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Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
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Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
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Performs other work-related duties as assigned.
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Minimal travel may be required.

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At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.