AD/Director, Biostatistics- Home or Office Based
Location: King of Prussia, PA, US
Cytel is shaping the future of drug development. As the world’s largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software. With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.
We are experiencing exponential growth on a global scale and hiring hands-on Associate Director, Biostatistics for our Project-Based Services (PBS) division. As a seasoned Biostatistician supporting clinical trials, you will have a strong track record of leading clinical studies, with a dedication to high quality service and outcomes, to lead a variety of projects for domestic and international clients, in a fast-paced CRO environment. Responsibilities will include project based work in Phase I-III studies, DMC involvement as an Independent Statistician, client interface and communications from project inception to submission, protocol/SAP/Charter writing and/or review, project management skills with multi-functional team members, hands-on stats and programming involvement including production/review of derivations and code.
You will have the ability to effectively convey statistical concepts to non-statistical personnel, experience in more advanced design methodologies and statistical techniques, good communication and presentation skills, project management and team leadership, and good organizational skills with the ability to multi-task.
This is a U.S. home-based position, with the option to work from our office locations in King of Prussia, PA or Waltham, MA.
Statistical responsibilities include:
- participating in the development of study protocols, including participation in study design discussions and sample size calculations;
- developing statistical analysis plans (SAPs), including analysis data and TLG specifications;
- performing statistical analysis;
- interpreting statistical results;
- preparing final analyses and outputs, including integrated summaries for submissions
Leadership responsibilities include:
- leading study activities, training and supervising Cytel’s staff;
- performing general project management;
- supporting business development for new project work;
- utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
- mentoring statisticians that may be new to certain types of studies and/or therapeutic areas;
- leading by example, as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
- being adaptable and flexible when priorities change
What you offer:
- PhD or Master’s degree in a related field from an accredited US institution of higher education.
- 10+ years working in clinical trials with at least 3 years working in a CRO environment.
- 5+ years of managing and/or leading Biostatisticians or cross-functional teams.
- Clinical trial designs in Phase I IV studies, with experience in Adaptive or Group Sequential designs a plus.
- Thorough understanding of statistical principles.
- Experienced in SAS programming, and knowledge of SAS procedures and other statistical software (i.e. R, EAST)
- Submissions experience preferred.
- Experience presenting to the DMC, blinded and un-blinded results
- Adept in CDISC ADaM / SDTM standards, with experience in the generation of ADaM specifications and QC of datasets strongly desired.
- Excellent communication and organizational skills.
- Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
- In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
- Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.