Career Openings
Experienced CRO Biostatistician, Full Time
Adaptive Biostatistician, Full Time
Biostatisticians in Cambridge, MA or Chesterbrook, PA
Experienced CRO Biostatistician
Join Cytel, the world leader in the design, interim monitoring and software development of adaptive clinical trials. An adaptive trial utilizes accumulating data to modify aspects of the study as it continues, without undermining the validity and integrity of the trial. This is one of the most exciting advances in clinical trial design in the past 20 years and is beginning to have a huge impact within the biopharmaceutical industry.
If you have a Ph.D. or Masters degree in Statistics or Biostatistics or a related health science field (i.e. MPH), possess an entrepreneurial spirit, and are excited at the prospect of working at a dynamic company involved in state-of-the-art research, development and implementation of new ways to run trials, we want to talk to you.
Prior clinical trials experience is helpful but talent, enthusiasm and excellent communication skills are more important. Familiarity with Bayesian methods, including WinBUGS, is a plus.
At Cytel, you will grow professionally through consulting interactions with biopharmaceutical clients and through participation in the development of breakthrough software that is helping leading companies, government agencies and research centers change the way clinical trials are designed and conducted. Cytel's software products East, StatXact and LogXact are unique, award winning design and analysis tools used by 47 of the top 50 biopharmaceutical companies, as well as academic research sites and the FDA.
Based either in our Cambridge, MA or Chesterbrook PA office, the Biostatistician performs analysis of clinical trial data and provides statistical input into the reporting of clinical trial results. Responsibilities include:
Provides statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data).
Communicates with clients regarding study protocol or statistical analysis issues.
Writes detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.
Work with the Senior Biostatistician(s) to design adaptive clinical trials that involve innovative statistical methods.
Analyzes clinical trial data producing accurate results representing the outcome of the trial.
Validates statistical output.
Accurately interprets statistical results and concepts.
With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report.
Provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).
Participates in interactions with regulatory agencies, as required.
Collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues.
Minimum Requirements
1-5 years biostatistical experience in the clinical trials or health research environment with a Ph.D. in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment OR Masters degree in Statistics or Biostatistics or a related health science field (i.e. MPH). Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials. SAS proficiency including BASE and STAT; GRAPH preferred. Utmost attention to detail and accuracy is absolutely required.
Preferred Requirements
The candidate should have a broad knowledge of statistical methodology, including both Bayesian and frequentist methods. Plus a broad knowledge of software packages such as SAS, R, S-Plus, and Winbugs.
Position Type
The position is full-time and reports to the Vice President of Clinical Services.
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
To Apply
Please email with your resume and cover letter attached to: careers@cytel.com with subject line: Biostatistician - CRO.
Email applications only, please
Careers Continued
Adaptive Biostatistician
Join the world leader involved in the design, interim monitoring and software development of adaptive clinical trials. An adaptive trial utilizes accumulating data to modify aspects of the study as it continues, without undermining study validity and integrity. This is one of the most exciting advances in clinical trial design in the past 20 years and is already having a huge impact within the biopharmaceutical industry.
If you have a Ph.D. in statistics or biostatistics, possess an entrepreneurial spirit, and are excited at the prospect of working at a dynamic company involved in state-of-the-art research, development and implementation of new ways to run trials, we want to talk to you. Prior clinical trials experience is helpful but talent, enthusiasm and excellent communication skills are more important. Familiarity with Bayesian methods is a plus.
At Cytel you will grow professionally through consulting interactions with biopharmaceutical clients and through participation in the development of breakthrough software that is helping leading companies, government agencies and research centers change the way clinical trials are designed and conducted. Cytel's software products East, StatXact and LogXact are unique, award winning design and analysis tools used by 47 of the top 50 biopharmaceutical companies, as well as academic research sites and the FDA.
As a Cytel biostatistician based in our Cambridge, MA office, you will:
Design adaptive and group sequential clinical trials for biopharmaceutical clients
Provide training to clients on the use of the East software
Manage projects and client relationships
The right candidate combines a high-degree of technical and communication skills with excellent consulting instincts, excited by the statistical and client challenges, and motivated to succeed through a stimulating reward structure.
This is a unique opportunity to influence clinical practice by providing innovative software tools and services to advance the process of drug development.
Position Type
The position is full-time and reports to the Vice President of Clinical Services
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
To Apply
Please email with your resume and cover letter attached to: careers@cytel.com with subject line: Biostatistician - Adaptive
Email applications only, please
Careers Continued
SAS Programmer
Join Cytel, the world leader in the design, interim monitoring and software development of adaptive clinical trials. An adaptive trial utilizes accumulating data to modify aspects of the study as it continues, without undermining the validity and integrity of the trial. This is one of the most exciting advances in clinical trial design in the past 20 years and is beginning to have a huge impact within the biopharmaceutical industry.
The Clinical SAS Programmer creates SAS programs in support of sponsor's clinical trials according to Cytel SOPs and guidelines. This programmer will create, document, validate, process, and maintain statistical programs and macros that generate analysis datasets, tables and graphics with high quality per agreed timelines. For the project lead position, the Clinical SAS Programmer will provide direction and oversight to programmers in creating sponsor deliverables.
Based either in our Cambridge, MA or or Chesterbrook, PA office, the Clinical Programmer's primary responsibilities can include the following (depending on experience level):
Act as lead programmer to write SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan: Summary Tables, Data Listings, Graphs, Integrated Analyses for regulatory submissions.
Act as quality control programmer to validate SAS programs that produce analysis datasets and analyses specified in the Statistical Analysis Plan
Ensure SAS programs adhere to SOPs, guidelines, and specifications
Ensure SAS program output matches the requirements of the Statistical Analysis Plan
Consult with managerial, statistical, data management, and medical writing personnel to clarify program intent, identify problems, and suggest changes.
Create derived-analysis datasets
Execute analyses specified in the Statistical Analysis Plan (SAP) under the guidance of the project statistician
Ensure specifications and documentation are correct and complete
Analyze information and evaluate results to choose the best solution and solve problems.
The successful candidate will have a combination of the following skills/experience:
BS, plus five year experience, or MA, plus one year experience
SAS programming experience in the pharmaceutical, biotechnology, and/or contract research organization industries
Extensive knowledge of Base SAS, SAS/GRAPH, SAS/STAT, and ODS
Experience working with heterogeneous data structures
Ability to work independently and adept at managing multiple competing tasks
Good understanding of clinical data and pharmaceutical development
Knowledge of SDTM, ADaM, FDA and ICH guidance
Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials
Knowledge of SAS programming techniques needed to produce outputs in accordance with specifications
Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by phone and by email
Position Type
The position is full-time and reports to the Vice President of Clinical Services
Multiple positions open
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
To Apply
Please email with your resume and cover letter attached to: careers@cytel.com with subject line: SAS Programmer.
Email applications only, please