Statistician (Medical Affairs)

job summary:

Statistician (Medical Affairs)

8 Month Contract | Remote

MUST HAVES

• PhD (3+ yrs) OR MS (6+ yrs) in Biostatistics, Statistics in Pharma/Biotech
• Exp. applying statistical methods in biomedical or pharmaceutical research
• Strong SAS skills (R preferred)
• Strong grasp of clinical study design, medical literature, regulatory context
• Translates complex statistical methods into clear scientific insights

The Statistical Scientist will serve as a key member of cross-functional teams, providing expert statistical support across clinical and medical affairs studies. You'll independently lead the statistical strategy and analysis for assigned projects whether clinical trials, observational studies, biomarker/PK-PD analyses, or exploratory research and ensure all deliverables meet the highest scientific and regulatory standards.

Depending on project scope, you may act as the lead statistician for a study, program, or regional initiative, collaborating closely with colleagues in Clinical Development, Medical Affairs, and Data Science. You may also contribute to methodological innovation-validating complex statistical techniques, consulting with peers, or developing new approaches for novel study designs.

location: Telecommute
job type: Contract
salary: $70 - 80 per hour
work hours: 9 to 5
education: Masters

responsibilities:

• Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers analyses
• Translates scientific questions into statistical terms and is responsible for the quality and timeliness of corresponding statistical deliverables
• Independently provides statistical advice related to study design, selection of endpoints, population, PK/PD or biomarkers for routine studies.
• Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)
• Under the supervision of an experienced statistician, may support more complex studies or asset level analyses (i.e., integrated summaries, regulatory, payer dossier and publications)
• Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).
• Collaborates and communicates effectively with the other Data Science functions; in particular the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables.
• Is responsible to develop a reliable network of academics, regulators and industry peers as well as investigate and share new statistical methodology

qualifications:
Required:

• PhD or M.S in Biostatistics, Statistics or related scientific field
• 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
• Good knowledge and skills in SAS required, knowledge of R preferred
• Good understanding of medical literature, clinical, regulatory, and commercial landscape
• Ability to understand, implement, and explain complex statistical methodology

#LI-LH1

skills: SAS, R Language, Statistical Programming


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.