Biostatistician Job at Penfield Search Partners Ltd, Philadelphia, PA

eE40TWNjU0tpalNFWG5yWlUvaFlueXZQQUE9PQ==
  • Penfield Search Partners Ltd
  • Philadelphia, PA

Job Description

No 3rd party agencies

Job Description: As a Biostatistician, you will lead projects with mentorship from senior staff to deliver the project statistician tasks/responsibilities. You will be involved with designing and analyzing medical devices and biological clinical trials. Successful candidates will work on regulatory submissions and directly contribute to company success by increasing the strength of study designs, interpretability of results, and facilitating collaboration with internal and external teams.

Responsibilities:

  • Apply knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research.
  • Develop and reviews statistical analysis plans based on study-specific documents and sound statistical methodology.
  • Develop, maintain, and produces statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
  • Interact with the sponsor, internal, and external team members.
  • Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation. Provide guidance for database structures for analysis.
  • Provide randomization schemes and appropriate documentation.
  • Programs/validate statistical tables with an emphasis on efficacy endpoints. Provide proper documentation and oversees the work of others who assist in programming/validating.
  • Understand and comply with all company policies and standard operating procedures.
  • Maintain a professional working relationship with sponsors, collaborating associates, and vendor personnel.

Requirements:

  • Ph.D. with 1-3 years’ experience, or a master’s degree with 3-5 years’ experience in Biostatistics, Statistics, or a similar field.
  • Candidates must have 3+ years CRO/Pharmaceutical/Medical Device experience.
  • Knowledge of FDA and ICH Guidelines required.
  • Knowledge of statistical design, analysis, and programming techniques utilized in clinical research required.
  • Good SAS® programming skills and understanding of database structures.
  • Ability to work on multiple projects at once.
  • Sense of ownership and pride in your performance and its impact on the company's success
  • Good time-management skills
  • Excellent interpersonal, written, and oral communication skills.
  • Having the ability to pivot and present/speak to clients is a plus
  • Experience with interim analysis, annual reporting, and TLF
  • Hands on experience with SAS and R
  • Know TLF development like back of hand

Job Tags

Interim role,

Similar Jobs

2.7 August Apparel, Inc.

E-Commerce Customer Experience Representative Job at 2.7 August Apparel, Inc.

 ...Short Description: The E-Commerce Customer Experience Representative is responsible for providing exceptional customer service and support to online customers. They serve as the primary point of contact for inquiries, order assistance, and issue resolution related... 

Ultimate Staffing

Warehouse Quality Control Lead Job at Ultimate Staffing

 ...We are seeking a dedicated and detail-oriented Lead/Quality Control Specialist to join our clients team at a packaging warehouse/distribution center in Wilmington, MA. This role reports directly to the Warehouse Manager and plays a key role in ensuring product quality... 

Domino's Franchise

Delivery Driver - 96 Route Job at Domino's Franchise

 ...Job Description For starters, a Delivery Driver must be at least 18 years of age, have had a valid driver license for two years and own...  ...necessary. Delivery Drivers work in the lunch, evening and late night dayparts. Candidates for this position must have a flexible... 

Liberty Health

LICENSED PRACTICAL NURSE - LIBERTY COMMONS OF COLUMBUS COUNTY Job at Liberty Health

 ...changes in orders as instructed or ordered by physicians. Performs other duties as assigned. Job Requirements: High school graduate. Licensed Practical Nurse, graduated from an accredited School of Nursing. Current, valid license from the North Carolina... 

Hirekeyz Inc

Scrum Master Job at Hirekeyz Inc

 ...Role: Scrum Master Location: Remote Duration:12+ Months Contract Job Duties: Manage the entire Scrum process for development team(s). Maintaining Scrum artifacts and Scrum Tool. Takes projects from assignment to implementation....