Biostatistician

ProPharma•Raleigh, NC

1d•Hybrid

About The Position

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Requirements

In-depth knowledge of statistical methodologies.
Demonstrated working knowledge of basic clinical trial design and analysis principles.
Working knowledge of CDISC standards and application of these standards to projects.
Strong computer skills, with evidence of programming skills (SAS or R) especially statistical inferential procedures.
Excellent English Communication skills (verbal, written & interpersonal).
Detail oriented, well organized.
Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Excellent Communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
Excellent team player, collaborative and able to work as part of an effective team.
Maintains a positive, results orientated work environment.
Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field.
Equivalent combination of education, training and experience will be considered.
Minimum 2-4 years' experience in clinical trials design and analysis or related field.

Responsibilities

Independently reads and comprehends study design and statistical sections of a protocol and appropriately adapts protocol language to a statistical analysis plan.
Independently able to perform or QC sample size calculations when provided with required operational design information.
Able to review data management documents to assess quality of the documents to support statistical analyses with supervision of more senior staff.
Develop Randomization specifications and programs based on study requirements with supervision of more senior staff.
Prepares draft statistical analysis plans and shells with support and oversight of senior staff.
Reviews PD for exclusion from analysis sets and implements into specifications and/or programs.
Participates in unblinding activities and incorporates unblinded treatment codes into algorithms/programming.
Able to read and understand common SDTM & ADaM domains and mapping algorithms.
Able to review common domains with oversight.
Learns the role that SDTM & ADaM plays in the standardization of clinical trials data/CDISC.
Able to prepare specifications for simple analysis data sets (CDISC and CDISC-like) independently or more complex data sets with senior oversight.
Able to develop programs to produce and perform statistical review of datasets, listings, tables and graphs as outlined by a statistical analysis plan.
Able to effectively QC TLFs, SDTM and analysis data sets (ADaM/non-ADaM) with supervision of senior staff.
Able to review the statistical section of CSR for statistical accuracy.
Able to support the lead statistician in maintaining biostatistical section of TMF.
Able to attend project team meetings as required.
Able to interact with both internal and external clients on project issues with supervision of senior staff.
Respects and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with.
Able to keep detailed records of time spent on each project to allow accurate billing.
Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
Develops knowledge of clinical research including awareness and understanding of how biostatistics interacts with other team members on a project.
Perform other work-related duties as assigned.