Assoc Dir, Clinical Statistics & Programming

 •  Pharsight Wilmington, DE and Malvern, PA

Biotech/Pharma

Salary depends on experience
Posted on 10/23/17
Wilmington, DE
Biotech/Pharma
Salary depends on experience
Posted on 10/23/17

Synchrogenix now offers additional technologies and services that expedite the regulatory process. 

These include:

  • The only artificial intelligence assisted medical writing service in the pharmaceutical industry. This transformative technology helps clients to better meet global transparency and disclosure requirements. 
  • Submission Management - our suite of products consists of the solutions regulatory operations professionals need to efficiently manage and publish, validate and review eCTD submissions.
  • Regulatory Services - submission and publishing services for marketing and pre-marketing applications as well as subsequent lifecycle submissions to support original applications.
  • Document Management - an intuitive, affordable document management system that reduces complexity from a user perspective while meeting the same robust standards for security and regulatory compliance

This combined knowledge makes Synchrogenix the consultancy of choice for life science and biotechnology companies worldwide. 

 Synchrogenix was named one of the INC 500/5000 Fastest Growing US Companies in 2012, 2013, and 2014 and has been named a Best Place to Work multiple times.

 

Corporate Culture:

Synchrogenix was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual—regardless of experience level—has something to teach and something to learn.

 Synchrogenix has built its culture on:

  • Being fast and flexible, non-hierarchical, apolitical, and non-defensive
  • Active participation—nobody sits on the sidelines
  • Teamwork—the company’s success is important to all of us
  • Cross-functional communication (lots of it) and a high-tech culture that works to have everyone on the same page
  • Disciplined leadership that inspires passion and commitment
  • Personal accountability
  • Strong peer and management support for those who want to learn
  • A calm and professional workplace—no drama!

 

Job Overview:

The Associate Director of Clinical Statistics and Programming will serve as an expert consultant for our clients by being able to understand the sponsor’s raw clinical or non-clinical data and recommend collection, planning and analysis that result in a streamlined process.  The role will be responsible for preparing and writing SAPs delivering study level analysis and datasets that are programmed to address the needs of the clinical program and the writers as well as the anonymization and future development of regulation.  One of the key opportunities for immediate impact is in pooling strategy, conversion to CDISC/SDTM standards for integration and pooled datasets to reduce the timeline for submission.  By creating a standard efficient process, the role will evaluate how our AI technology can automate redundant or logical tasks both in the initial data set and within anonymization regulations and the meet the needs of the study.  We need someone who can be a client liaison, can speak from a knowledgeable process perspective, future evolution perspective and be client facing.  Managing the detailed, high-level overview of the specifications and metadata for all SDTM domains and mapping datasets from a non-CDISC structure to a CDISC SDTM structure.  The right individual will be looking to lead the industry by changing the paradigm and reducing the bottlenecks in this process.  Knowledge of PK/PD data and analysis is a strong plus in bridging the future of drug development.

Responsibilities

  • Utilize statistical modeling to prepare datasets
  • Liaise with clients as an expert consultant to align statistical models prior to study delivery
  • Develop Statistical Analysis Plans for Clinical studies within the Protocol in order to truly test what needs to be tested
  • Translate SAP into criteria for SAS Programmer.
  • Author SAP Model for protocols 
  • Innovate and identify opportunities for tech enabled capabilities
  • Develop process, governance and training for service line and drive into operational models through education platforms and accountable parties.
  • Create training
  • Work with Director of Team Leads(resourcing and professional Development), Sales and Marketing, and Operations as business partners to drive process, growth and education. Lots of consulting work right now where we could consult on statistical analysis.   May need more programmers next year if we grow this submission work quickly.  Up to 10 more programmers.  (Please don’t forget cross Certara baseline capabilities (they have some statisticians-this just isn’t heir focus) and the capabilities already existing in SPI that can be trained)
  • Ability to jump in and add to other service areas or offerings, role for biostats in data disclosure (set up process) resources are more flexible
  • Ability to evolve as industry trends evolve-challenge the status quo
  • Strength and awareness on regional data standards and expectations- (ie Japan, no rounding for significance etc.) 

Synchrogenix is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status, or any other characteristic protected by law.  Synchrogenix makes reasonable accommodations for disabled employees and applicants.  Synchrogenix only employs individuals with the right to work in the country/ies where the role is advertised.  We are committed to fostering, cultivating, and preserving a culture of diversity and inclusion. The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that our employees invest in their work represents a significant part of not only our culture, but our reputation and achievement.

Requisition ID1161

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