Job Description

PRINCIPAL STATISTICIAN II (REMOTE) - SIMPLY BIOTECH

OVERVIEW

Are you looking for a new career opportunity with an exciting company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a REMOTE Principal Statistician II who possess:

• Master’s degree with 8-12 years or Doctoral degree with 6-10 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry
• Direct participation in design, planning, conduct, analyses, and reporting of clinical trials
• Direct participation in regulatory submission activities
• Must be an expert with SAS (certification is a huge plus)

Email your resumes to ajones@simplybiotech.com or call 858.251.3562

FULL DESCRIPTION: THE PRIMARY RESPONSIBILITIES OF THIS POSITION ARE TO PROVIDE STATISTICAL CONSULTING TO CLIENTS IN THE BIOTECH/PHARMACEUTICAL INDUSTRY IN THEIR DRUG DEVELOPMENT PROGRAMS WITH A FOCUS ON PROTOCOL/STUDY DESIGN, ANALYSIS PLANNING, REGULATORY SUBMISSION STRATEGIES, REGULATORY COMMUNICATION, AND ASSIST WITH BUSINESS PROPOSALS.

The selected candidate will further possess:

• Deep understanding statistical concepts and methodology related to clinical trials and drug development
• Comprehensive knowledge on regulatory guidelines
• Excellent organizational and project management skills
• Excellent interpersonal and communication skills

The selected candidate will be responsible for the following:

• Provide statistical consulting to clinical study design
• Review study protocols and write statistical sections
• Conduct sample size and power calculations
• Propose randomization methods and designs
• Lead regulatory submission strategy planning for statistics function
• Identify issues, and provide solutions to clinical operation and data management for issues that potentially impact data analyses
• Review and provide comments to statistical analysis plans that are written by the 3rd party
• Develop statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions
• Write statistical reports for results interpretation, both for individual studies and integrated analyses for regulatory submissions, if needed
• Prepare statistical sections of clinical study reports if needed
• Participate in clinical results interpretation meetings, both for individual studies and integrated analyses for regulatory submissions
• Work with medical writers to assist with clinical study reports and ISS/ISE reports preparation
• Review clinical study reports and other regulatory submission documents
• Participate in regulatory communication
• Lead statistical methodology research and stay current on statistical methodology and drug development
• Mentor junior statisticians in their support of client projects
• Ensure that statistical personnel follow the standard operating procedures
• Assist with preparation of business proposals

For immediate and confidential consideration, please email your resume to ajones@simplybiotech.com call 858.251.3562

More information can be found at www.simplybiotech.com

Company Description

Recruiting is a lost art. We’ve brought it back to the basics. Here’s how. Helping People Succeed. As a part of the TalentZök family, we focus on helping you identify the best talent. Whether you’re seeking temporary help or help on a direct hire basis, Simply Biotech and the TalentZök family of companies can connect you to the right person for the job. Biotech. It’s all we do. We believe that effective and successful recruiting must be specialized. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. At Simply Biotech, we focus only on the biotech/device industry. No “resume farming” here The most talented people rarely post their resumes to job boards. They are out there working, untapped. Many don't even know they are interested in better opportunities because they are passive job seekers. You want the best person for the job and chances are, the best person doesn't have their resume posted. They may even be working for your competitor. So searching the job boards along with every other biotech firm won't get you the result you're looking for. Only old-fashioned recruiting - picking up the phone, networking and finding the talent in the workforce - will get you the perfect match. Thank you for calling We've picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? At Simply Biotech, customer service is our priority. We return calls promptly. We don't let you fall through the cracks. It sounds so simple yet so few know how to do it right. We do our homework - to save you time Before filling a position, we speak with many of the people involved in making the decisions and ask quite a few questions. While this takes a little longer in the beginning of the process, it allows us to better understand what’s most important in a candidate. That way, we send only qualified candidates who will be in line with what you’re looking for. Many recruiters just forward resumes to clients. At Simply Biotech, we conduct a thorough interview with each candidate before presenting them to you. We speak with them about their experience at each position and find out who they reported to, what their responsibilities were, and why they left. Many times this uncovers information that is omitted in the resume and that may be vital to your decision. We feel that it is our responsibility to thoroughly screen candidates before presenting them to you. This process results in fewer, better candidates for you to consider - and saves you time.