Biostatistician, Late Development Statistics

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enable the discovery development regulatory approval manufacturing and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

• Develops coordinates and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.

• Interacts with Clinical Regulatory Statistical Programming Data Management and other our Companys Research Laboratories Scientists in analyzing clinical trials and in coordinating other statistical activities for clinical drug/vaccine projects under supervision.

• The incumbent may initially work in a specific disease therapeutic area.

Primary activities:

• Shadowing senior statisticians serves as statistical representative in the cross-functional teams for the clinical trial planning execution and reporting.

• Under supervision of senior statisticians participates in study design; performs sample size calculations and simulations to support protocol development.

• Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis.

• Participates in database design meetings and reviews relevant study documents including CRF Data Validation Plan and Medical Monitoring plan to ensure that the data evaluated are in high quality and satisfy analysis requirements.

• Collaborates with the statistical programming staff to provide definitions documentations and reviews derived variables needed for planned analysis; ensures that all programs meet analysis requirements internal standard operating procedures and external regulatory requirements.

• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Reviews study results to ensure all the deliveries in high quality.

• Under supervision of senior statisticians prepares oral and written reports to effectively communicate results of clinical trials to the project team management regulatory agencies or individual investigators.

• Involved in research activities for innovative statistical methods and applications in clinical trial development

Education and Minimum Requirement:

• Masters degree or equivalent in statistics/biostatistics or related discipline.

Required Skills and Experience:

• Knowledge of statistical analysis methodologies and experimental design.

• Familiar with statistical and data processing software e.g. SAS and/or R.

• Good oral and written communication skills. Able to work effectively with personnel with different functional background.

• Must also demonstrate the ability to learn be proactive and motivated and consistently focus on details and execution.

BARDS2020

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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