Principal Statistical Programmer, Late Stage - US based, Remote
Company: POINT Biopharma
Posted on: May 14, 2022
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
Location of work
The position will be working remotely with the anticipation of
travel for team and client meetings. Currently, our employees are
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
The Principal Statistical Programmer will be responsible for
providing timely support to the study team on all programming
requests, including internal programming deliverables requested by
POINT study team and oversight of CRO statistical programming
This position will report to Director of Statistical Programming
and will work closely with cross-functional teams on single
possibly multiple clinical development programs. Typical requests
include internal ad-hoc requests, periodic safety and efficacy
updating report, TLF output supporting presentations, publications
and health authority submissions.
- Demonstrate extensive understanding of SAS programming concepts
and techniques in pharmaceutical/biotechnology setting,
independently develop, test, and document SAS programs and macros
for programming deliverables.
- Create, maintain the programming specifications for the data
sets, review the programming specifications provided by CRO.
- Create and validate SAS outputs including SDTM and ADaM
datasets, and TLFs or ad-hoc output per study team request.
- Responsible for the creation and accuracy of regulatory
submission data and clinical summary report package. Understand and
perform in accordance with regulatory standards.
- Create and validate SAS outputs supporting presentations,
publications and health submissions.
- BS in computer science, mathematics, statistics or related
analytic field, MS in statistics/biostatistics highly
- Minimum 7 years of hands-on statistical programming experience
in CRO, biotech, or pharmaceutical setting, including SAS/BASE,
SAS/STAT, SAS/GRAPH and SAS Macro languages.
- Working knowledge in all aspects of clinical trials from
initial study set-up to study completion with an excellent
understanding of the roles and responsibilities of related
disciplines, biostatistics, statistical programming and CDM.
- Broad knowledge of all CDISC requirements related to SDTM and
ADaM, including define package, reviewer's guide and submission
- Working knowledge GCP/ICH standards, 21 CFR Part 11 and FDA
requirements with prior experience filing NDA/MAA/BLA
- Must have oncology working experience with solid tumor study
experience highly preferred.
- Strong analytical and problem-solving skills
- Ability to work independently, while being a collaborative team
member in a dynamic fast-paced and lean environment
- Organized with high attention to detail, accuracy and
- Excellent interpersonal, and verbal and written communication
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
- 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
If what we are saying resonates with you, please submit a cover
letter and resume.
- Health Care Plan (Medical, Dental & Vision) - effective day
- 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
- $50 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.
We do not accept unsolicited inquiries or resumes from
Keywords: POINT Biopharma, Garland , Principal Statistical Programmer, Late Stage - US based, Remote, IT / Software / Systems , Garland, Texas
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