Assoc Dir, Biostatistics

2 weeks ago


Remote, India Syneos Health Clinical Full time

**Description**

**Associate Director, Biostatistics**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Develops department Standard Operating Procedures (SOPs) and guidelines, in collaboration with Statistical Programming, promoting standardized and consistent processes to maximize the efficiency of the department.
- Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget.
- Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching.
- Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies meeting the business needs of the Biostatistics department.
- Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff.
- As applicable, meets with subordinate managers, to evaluate and develop solutions for project resourcing, quality, timelines, standard processes, and training needs. Keeps senior management informed of decisions and issues which impact the department.
- Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistical department mentor. Develops and provides training for Biostatistics associates.
- Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges.
- Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience.
- Conducts senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents.
- May participate in, or lead departmental or corporate initiatives.
- Supports business development activities.
- Performs other work-related duties as assigned.
- Minimal travel may be required.

**Qualifications**

**What we’re looking for**
- Graduate degree, or equivalent, in biostatistics or related discipline.
- Functional expert who is ready to do hands on Biosats activities like reviewing Randamizations; SAP reviews for our Biostats teams & guide & mentor them wherever required.
- Strong experience in people management who can manage teams across India, Australia, NA & Europe.
- Extensive experience in managing complex Studies & multiple client engagement & consultation.


**Get to know Syneos Health**

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

**Additional Information**