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Senior Statistical Programmer

Employer
ClinChoice
Location
United States, Raleigh (NC)
Salary
Competitive
Start date
20 Mar 2019
Closing date
28 Mar 2019

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Job Details

Description:
TalentSource Life Sciences is currently searching for a Senior Statistical Programmer to join one of our biotechnology partner companies in the United States. This is a permanent, office based position in Raleigh, NC.

The successful candidate will be working on studies dedicated to one client .

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

The Senior Statistical Programmer will serve as a program or study-level programmer in a defined development program, support the programming and analysis of a clinical study within current or future compounds, and serve as a lead developer of new technologies, such as innovative visualization techniques or other non-traditional pharmaceutical programming methods.

Job specific tasks and responsibilities:
  • Lead and support statistical programming activities for assigned clinical studies, submissions and development initiatives. Coordinate and provide input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.
  • Provide high level of effective collaboration for statistical programming initiatives with key members within various internal groups to facilitate understanding of statistical programming services and work product.
  • May program, validate, maintain and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following Sponsor standard operating procedures and working documents.
  • Where applicable, develop innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base.
  • Ensure that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standard requirements of regulatory agencies and other departments within the Sponsor.
  • Ensure that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following procedures and standards. Develop specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
  • Support direction, motivation and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.
  • Support development and rollout of new standards and processes with respect to own statistical programming operations team.
  • Ensure compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
  • Contributes to and manages statistical programming timelines and commitments to timelines for the study and/or project.
  • Mentors statistical programmers and develops standards across all programs.
  • Provide input into and enforce the department's standards. Enforce SOPs and working practices. Adhere to the Sponsor's SOPs and working procedures.
  • Such other responsibilities and projects that the Sponsor may assign.


Education, Qualifications & Experience:
  • Master's (preferred) or Bachelor's degree in a relevant field
  • Strong experience in statistical programming within the Pharmaceutical Industry with a proven successful track record in pharmaceutical development.


Skills & Knowledge:
  • Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.
  • Advanced SAS Software Programming skills, including experience with advanced DATA step, SQL and macro development to solve complex programming tasks.
  • Good clinical studies design and analysis experience, including comprehensive understanding of drug development phases, clinical studies designs, efficacy endpoints and assessments and safety endpoints and assessments.
  • Working knowledge of statistical principles, including descriptive and inferential statistical (parametric and non-parametric) methods and experience in using respective SAS procedures.
  • Excellent written and verbal communication. Extensive experience in communicating with all levels of personnel across various departments, in domestic and international environments. Able to communicate complex quantitative ideas clearly.
  • Excellent command of English, both verbal and written.
  • Demonstrated experience in leading and participating in collaborative work teams at local and global levels, preferably including CROs.
  • Advanced knowledge of SDTM and ADaM programming requirements and practices. Ability to define and implement new SDTM and ADaM domains into clinical studies practices.
  • Good understanding of regulatory submissions requirements for new product development and support.
  • Good leadership abilities and interpersonal skills to mentor and lead statistical programmers to successfully deliver high quality projects, study team statistical programming work product and oversee CRO statistical programming teams.
  • Tact and discretion in order to obtain cooperation within team environments in an effort to facilitate open communication and team effectiveness.
  • Good project management skills including experience in managing multiple tasks and personnel concurrently.
  • Ability to work under pressure and without close supervision.
  • Able to adapt to change.
  • Able to work in a multicultural global environment.
  • High level of analytical ability, exhibiting characteristics that are structured and methodical to ensure that sound, decisions are made.
  • Advanced ability to identify issues and proactively prevent statistical programming problems for assigned product development program. Ability to communicate these issues and solutions to study leads in statistical programming ensuring standardization and homogeneity of SDTM, ADaM datasets, and data integration across the program.
  • Able to use facts, data, measurements and to have a systematic approach to solving complex statistical programming tasks.
  • Able to plan, perform, trouble-shoot and make decisions based on precedent, company policies, Sponsor procedures, international and national regulations and Good Clinical Practice.
  • Judgement skills to work accurately and efficiently towards quality results and to create new processes and procedures, when necessary.
  • Proactive in evaluating study and project reports to detect problematic issues.


The Benefits of Working for TalentSource in the US
  • Full health insurance benefits that include health, dental and vision
  • 401K Plan with 5% company match after satisfying 90 days of employment
  • Short term and long term disability insurance
  • Life insurance
  • Paid vacation, sick leave and holidays
  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Full performance and development process with
  • Team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001750

If you would like to discuss the role before applying through the website, please contact Holly.Price@cromsource.com for more information.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Why TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organization. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertize and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Keywords: Statistical Programmer, Stats Programmer, SDTM, ADaM, SAS Programmer, SAS, SQL, DATA step, Pharmaceuticals, Pharma, Outsourced, Outsourcing, CRO, Contract Research Organization, Permanent

Skills: SAS Programmer, Statistical Programmer, SAS, SQL Location: United States, Raleigh (NC)

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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