Manager, Biostatistics

Title: Manager, Biostats

Business Unit: Global Clinical Development

Job Grade: Manager

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Exhibit self-drive as you Take charge and lead with confidence

Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys

JOB DESCRIPTION:

Position Summary:

Sun Pharma is seeking an experienced and motivated Statistician to join our rapidly growing organization

Reporting to the Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions

This person will work cross-functionally with internal departments and external resources on Biostatistics-related issues, ensure adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate, and apply technical expertise to the development of biostatistics standards and procedures

Responsibilities

Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected

Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol

Assist in developing project and functional standards of data collection and analysis, and implement these standards

Database Activities: Collaborate with data sciences, statistical programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs

Contribute to data monitoring plans

Develop and implement project specific data standards

Ensure accuracy and consistency of data released for statistical analysis

Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology

Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results

Provide sufficient details to allow programming implementation

Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately

Determine need for development of novel statistical methodology

Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analysis

Prepare oral and written reports to communicate results

Represent data and statistical sciences on project issues at management review and project team meetings

Provide in-depth statistical review for scientific reports and publications

Ensure the accuracy of the statistical component of scientific reports and publications and high quality

Project team involvement: Partner with clinical and regulatory to create development strategies for assigned project

Represent department on project team(s) to provide statistical input to compound/drug development and align with functional management

Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional management

Training and Supervising: Train and mentor staff on statistical methodology and operations

Participate in statistical methodology and operations

Participate in department seminars, short courses and presentation of scientific articles

Gain expertise in innovative statistical methods

Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff

People managers will manage 2 or more direct reports

Regulatory Activities : Ensure that all applicable regulatory requirements for work processes are met

Critically review regulatory submission documents

Participant in discussions with regulatory agencies as needed

Validate external statistical software to meet SOPS and REGULATORY REQUIREMENTS

Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values

Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the statistics function

Ensure compliance with department standards, GxP and best operating practices for staff and self

Complement all assigned training on time

Required Qualifications:

Demonstrated good understanding of Phase I to Phase IV drug development

Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance

Knowledge of statistical analysis software SAS and R

NDA/BLA experience with eCTD submission is a plus

Dermatology or oncology drug development experience is a plus

Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines

Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company

Attention to detail and quality are critical to success

Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others

Use teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required

Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company

Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues

Educational Qualification: Ph

D

or M

S

in Biostatistics or Statistics

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth

Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact

Let s create a brighter future together!