Consultant (Stats)

Frazer, PA

Posted: 03/18/2019 Job Number: JN -032019-10546
Principal Statistician:

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Principal Statistician
  • Location: Frazer, PA
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: $65.00 hour paid weekly with benefits options
  • Employment Type: Contract 6 months with possible extension or conversion
Environment: This client is a worldwide leading generic pharmaceutical company and one of the top 15 companies in the industry. With over 45,000 employees in 60 countries worldwide, they are proud to say that our employees are the reason for our success . They believe in empowering employees, presenting them with new challenges and letting them grow and develop professionally. Isn t this the type of company you want to work for?

Job Scope: This position will provide statistical support to clinical studies within Global R&D. The support includes, but not limited to, study designs and data analyses.
  • Provides study design input and consultation for clinical endpoint assessment and sample size planning
  • Writes, or oversees the writing of, statistical analysis plans and validation plans
  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of Teva products
  • Conducts analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses
  • Responsible to develop the dataset specifications for ADaM datasets
  • Responsible for the QC of SDTM and ADaM datasets as well as tables, listings and graphs to support the CSR, submissions and publications
  • Responsible to review study data to identify data issues that may impact the validity of the study and corresponding statistical analyses
Skills Needed:
  • Ph.D./MS in Statistics/Biostatistics (or related field)
  • 5+ years of related experience
  • Training and experience in statistics, drug development, and clinical research
  • Knowledgeable about statistical principles and appropriate software and tools
  • Candidates should be hands on - not director level.
  • Data specifications and table reviews are also a must
  • Ability to program using SAS, knowledge of R is beneficial
  • Knowledge of relevant ICH, FDA and CHMP guidelines
  • Knowledge of CDISC requirements including SDTM and ADaM
  • Excellent presentation and written communication skills
  • Ability to communicate with non-statisticians to interpret statistical findings
  • Good organizational and problem-solving skills
  • Demonstrated project and technical leadership qualities, and creative and strategic thinking required
EOE/ADA

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