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POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.
TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.
Location of work
The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are mostly working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.
Reporting to the Senior Director, Statistics, the Associate Director will provide an expert-level hands-on and technical support to all clinical development programs in POINT. The Associate Director will utilize the statistical expertise in the design, analysis, and interpretation of clinical trial programs; submission and defense of regulatory filings; and the generation of evidence to support product commercialization and reimbursement. This position will work cross-functional teams on multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.
Objectives
- Apply expert skills to investigate and use novel, statistical approaches for relevant statistical issues. This includes application of modelling and simulation to improve study design, and identification of opportunities to improve statistical methodology and/or provide practical solutions for problems.
- Conduct analyses of internal and external information to inform design decisions and the development of decision criteria.
- Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells.
- Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
- Interpret study results and provide review of statistical summary reports to study results.
- Plays a critical role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
- Contributes to the development of best practice to improve quality, efficiency and effectiveness.
Requirements
- PhD in statistics or biostatistics with at least 7 years of relevant experience or MS in statistics or biostatistics with at least 10 years of relevant experience.
- Experience in using or sound understanding of the value of Bayesian methods in scientific research preferred.
- Prior experience providing statistical support to early phase clinical studies preferred.
- Strong computational skills in R or SAS or other statistical applied software systems.
- Experience in oncology drug development within a pharmaceutical or biotechnology company is required.
Why joining POINT today will be the right career move for you:
There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:
- You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
- You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
- You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
- Most importantly, you will spend everyday working on something important
If what we are saying resonates with you, please submit a resume.
Benefits
- Health Care Plan (Medical, Dental & Vision) - effective day 1
- Retirement Plan (401k)
- Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
- Voluntary Income Protection – Premiums paid by employee
- Paid Time Off (Vacation, Sick & Public Holidays)
- $500 fitness reimbursement per year
- $100 cell phone reimbursement per month
All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.
POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
